MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-24 for SHUR-STRIP STERILE SKIN CLOSURE S-105 manufactured by Inmamedi.
[18788]
After switching to the new strip sterile skin closures from the much preferred, better quality strip skin closures, all rptr hears from surgeons and residents are complaints about the product. The strip closures do not work. The strip closures do not stick as well as the other brand strips. Frequent replacement of the ineffective strip skin closures increase surgical morbidity of the wound. Very bad scars are left. Any gain in cost differential is defeated by using the low quality strip closures due to frequent replacement of these ineffective strips. The strip skin closures are unsatisfactory and rptr strongly recommends that hosp immediately switch back to the good strips that work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001314 |
| MDR Report Key | 33214 |
| Date Received | 1996-05-24 |
| Date of Report | 1995-07-31 |
| Date Added to Maude | 1996-05-31 |
| 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 |
| 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 | SHUR-STRIP STERILE SKIN CLOSURE |
| Generic Name | SKIN CLOSURE |
| Product Code | FPX |
| Date Received | 1996-05-24 |
| Model Number | S-105 |
| Lot Number | 4259311 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34534 |
| Manufacturer | INMAMEDI |
| Manufacturer Address | 6316 AIRPORT FREEWAY FORT WORTH TX 76117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-24 |