Mona Lisa intrauterine contraceptive devices 의 안전성 경고

Safety alert

2011-07-29

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/press_20110801.html

Recall of two mona lisa intrauterine contraceptive devices (with photo) the department of health (dh) today (july 29) instructed a local medical devices supplier, cnw far east limited (cnwfe), to recall all batches of two of its intrauterine contraceptive devices (iucds), mona lisa cut 380a and mona lisa nt cu 380, from shelves following discovery of mislabelling and wrong packaging involving the two models. the discovery was by the dh's chai wan maternal and child health centre (mchc) when they served a family planning client yesterday. on opening a cut 380a package, staff discovered that an nt cu 380 device was found instead. "cut 380a has a life span of 10 years while nt cu 380 has only half that - five years," a dh spokesman stated. "as the client had expressed no preference on her choice, the nt cu 380 was inserted and she was also told so." being unusual, the incident was reported by the mchc to the medical device control office in the dh. the latter began investigation immediately and findings so far reveal that the entire production chain for mona lisa iucds actually takes place in belgium.   the spokesman said that although the two devices differ only in terms of life span and the dh is not aware of related notifications here or worldwide, to be prudent, the client was contacted. she opted for an alternative mode of contraception on learning of the matter.   "moreover, we have referred the case to our belgian counterpart for their follow-up action. meanwhile, cnwfe is also instructed to recall both products from shelves, pending investigation findings in belgium. however, at present, there is no evidence to indicate that clients with the devices inserted require removal," the spokesman said. given that sales records show that the devices have been distributed to health-care institutions and private doctors, the dh has brought the matter to relevant stakeholders' attention. "health-care professionals and retailers should stop supplying the said products to clients immediately. cnwfe has set up a hotline, 2388 2933, to answer related enquiries," the spokesman said. "and to cater for enquiries from mchc's clients, the dh will also operate a hotline, 2125 1133, from tomorrow onward," the spokesman added. the spokesman emphasised that the dh will be monitoring the recall besides continuing the investigation with belgian collaboration. ends/friday, july 29, 2011 issued at hkt 21:37.