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 CLOSURES, 1/2" X 4" S-105/S-106 manufactured by Inman Medical Corp..
[20198]
Product found not to stick as well as another similar product, therefore wounds do not stay closed and heal properly. Ctr has received no other complaints on subject acquisition to indicate that this is other than an isolated incident probably due to damaged packaging or extremes of heat in storage. Center will retain report of dissatisfaction in quality assurance data files and if add'l similar reports are received will initiate an investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000985 |
| MDR Report Key | 29090 |
| Date Received | 1995-12-28 |
| Date of Report | 1995-06-28 |
| 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 CLOSURES, 1/2" X 4" |
| Generic Name | SKIN CLOSURES |
| Product Code | FPX |
| Date Received | 1995-12-28 |
| Catalog Number | S-105/S-106 |
| Lot Number | 4-254307 |
| ID Number | TD50255Z |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30104 |
| Manufacturer | INMAN MEDICAL CORP. |
| Manufacturer Address | 6316 AIRPORT FRWY FORT WORTH TX 76117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-12-28 |