MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-28 for SHUR-STRIP STERILE SKIN CLOSURE manufactured by Inman Medical Corp..
[17759]
Skin closures do not adhere to the incision site even when other adhesive is placed on skin. Skin closures subsequently fall off prematurely before the incision has healed properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000986 |
| MDR Report Key | 29091 |
| Date Received | 1995-12-28 |
| Date Added to Maude | 1995-12-29 |
| 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 | 1995-12-28 |
| ID Number | TD50256Z |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30105 |
| Manufacturer | INMAN MEDICAL CORP. |
| Manufacturer Address | 6316 AIRPORT FREEWAY FORT WORTH TX 76117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-12-28 |