MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-24 for SHUR-STRIP * manufactured by Inman Medical Corp..
[18197297]
Sterile skin closures do not function. They do not adhere properly to the skin either with or without benzoin. If they can be made to stick to the skin, they fall off within one or two days. This is completely unsatisfactory as a skin closure device. It could compromise pt recovery, and increase postoperative complications. As a result, the surgeons working in general, gyn, and orthopedics svs constantly complain of the lack of quality of these strips and most simply refuse to use them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001782 |
| MDR Report Key | 70826 |
| Date Received | 1997-02-24 |
| Date of Report | 1996-03-08 |
| Date Added to Maude | 1997-02-26 |
| 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 |
| Generic Name | SKIN CLOSURE ADHESIVE |
| Product Code | FPX |
| Date Received | 1997-02-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 5138240 |
| ID Number | 6510-00-913-5874 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 70733 |
| Manufacturer | INMAN MEDICAL CORP. |
| Manufacturer Address | 6316 AIRPORT FREEWAY FORT WORTH TX 76117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-02-24 |