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 SKIN CLOSURE S-101 manufactured by Inman Medical Corp..
[27057]
The current skin closure tapes, strips are markedly inferior to another brand strips. Surgeon is experiencing complications with surgical wound closures in infants because the strips are overly stiff and have poor adhesive properties. Surgeon needs the other brand strips for use in pediatric surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001312 |
| MDR Report Key | 33213 |
| Date Received | 1996-05-24 |
| Date of Report | 1995-06-29 |
| 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 SKIN CLOSURE |
| Generic Name | SKIN CLOSURE |
| Product Code | FPX |
| Date Received | 1996-05-24 |
| Model Number | S-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34533 |
| Manufacturer | INMAN MEDICAL CORP. |
| Manufacturer Address | 6316 AIRPORT FREEWAY FORT WORTH TX 76117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-24 |