MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-20 for SKIN BOND CEMENT manufactured by Smith & Nephew, Inc..
[14300]
Since 10/94 rptr has purchased skin bond cement that has been defective. The glue prior to that was fine, now it appears to have no tackiness & is very thin. Rptr has reported this problem to the mfrs with no satisfaction. The problem continues. The skin around rptr's urinary opening, where the glue is applied, is beginning to breakdown, putting rptr in a life threatening position. Mfr claims that they have solved the problem & sent rptr product. The problem is not solved. Their is still very little tackiness when applied to the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000709 |
| MDR Report Key | 26732 |
| Date Received | 1995-07-20 |
| Date of Report | 1995-05-23 |
| Date of Event | 1995-05-17 |
| Date Added to Maude | 1995-10-11 |
| 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 | PATIENT |
| 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 | SKIN BOND CEMENT |
| Generic Name | BOND CEMENT |
| Product Code | EZR |
| Date Received | 1995-07-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27509 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | COLUMBIA SC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1995-07-20 |