MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-19 for ACTIVE LIPE (COLOSTOMY BAG) 22771 0003-0227-71 manufactured by Convatec.
[16267374]
Problem with colostomy bags. The adhesive between the flange and tape does not adhere to the skin properly. All of a certain lot number had this defect. Mfr is still shipping defective lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010432 |
| MDR Report Key | 57194 |
| Date Received | 1996-12-19 |
| Date of Report | 1996-12-17 |
| Date of Event | 1996-12-11 |
| Date Added to Maude | 1996-12-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVE LIPE (COLOSTOMY BAG) |
| Generic Name | COLOSTOMY BAG |
| Product Code | EZS |
| Date Received | 1996-12-19 |
| Model Number | 22771 |
| Catalog Number | 0003-0227-71 |
| Lot Number | 96038805 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 57693 |
| Manufacturer | CONVATEC |
| Manufacturer Address | PO BOX 5254 PRINCETON NJ 085435254 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-19 |