U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
suture - Product Code GAM
원인
The unique absorption profile of panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations.
조치
Customer notification letter was sent out on 3/28/2006 alerting the customer to the problem with the suture.
There were 2202 customers in the US and 10 international customers. This product is no longer being marketed by Ethicon. Its last shipment was 7/1/2002. There are US Military and VA Hospitals included. All International customers are the J&J; Medical Products Distribution Ctrs located in Australia, Canada, Hong Kong, Indonesia, Japan, Korea, Malaysia, Philippines, Taiwan, and Thailand.
제품 설명
Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide and 5% glycolide. The suture is coated with a copolymer composed of 90% caprolactone and 10% glycolide.