MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-24 for SKIN CLOSURE S-102 manufactured by Inman Medical Corp..
[17804766]
Skin closures do not adhere to the skin. Even after the application of mastisol or tincture of benzoine, these skin closures will not adhere properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001328 |
| MDR Report Key | 33229 |
| Date Received | 1996-05-24 |
| Date of Report | 1996-01-11 |
| Date Added to Maude | 1996-06-03 |
| 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 | SKIN CLOSURE |
| Generic Name | SKIN CLOSURE |
| Product Code | FPX |
| Date Received | 1996-05-24 |
| Model Number | S-102 |
| Lot Number | 9F22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34549 |
| Manufacturer | INMAN MEDICAL CORP. |
| Manufacturer Address | 6316 AIRPORT FREEWAY FT WORTH TX 76117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-24 |