MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-08-11 for RESTORE PLUS WOUND DRESSING 9965 manufactured by Hollister Incorporated.
[321393]
Skin stripping when product was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119193-2003-00002 |
| MDR Report Key | 478381 |
| Report Source | 00 |
| Date Received | 2003-08-11 |
| Date of Report | 2003-08-11 |
| Date Mfgr Received | 2003-07-29 |
| Date Added to Maude | 2003-08-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 2000 HOLLISTER DR |
| Manufacturer City | LIBERTYVILLE IL 60048 |
| Manufacturer Country | US |
| Manufacturer Postal | 60048 |
| Manufacturer Phone | 8476802849 |
| Manufacturer G1 | HOLLISTER INC. |
| Manufacturer Street | 366 DRAFT AVE |
| Manufacturer City | STUARTS DRAFT VA 24477999 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 24477 9998 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESTORE PLUS WOUND DRESSING |
| Generic Name | HYDROCOLLOID WOUND DRESSING |
| Product Code | MGP |
| Date Received | 2003-08-11 |
| Model Number | NA |
| Catalog Number | 9965 |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 467189 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE IL 60048 US |
| Baseline Brand Name | RESTORE PLUS HYDROCOLLID DRESSING |
| Baseline Generic Name | HYDROCOLLIOD WOUND DRESSING |
| Baseline Model No | 9965 |
| Baseline Catalog No | 9965 |
| Baseline ID | NA |
| Baseline Device Family | RESTORE PLUS HYDROCOLLID DRESSINGS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-08-11 |