MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-05-08 for MED/SURG SHOE 79-81135 manufactured by Smith & Nephew, Inc..
[51576]
The subject patient allegedly fell after a strap tab on the subject foot support (79-81135) broke apart. During the fall, the patient hit her sutured wound against a hard surface, which resulted in the re-opening of the wound. Surgical intervention was required to treat the re-opened wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020737-1997-00001 |
| MDR Report Key | 90270 |
| Report Source | 05 |
| Date Received | 1997-05-08 |
| Date of Report | 1997-05-08 |
| Date of Event | 1997-03-26 |
| Date Mfgr Received | 1997-04-16 |
| Date Added to Maude | 1997-05-14 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MED/SURG SHOE |
| Generic Name | FOOT SUPPORT |
| Product Code | IPG |
| Date Received | 1997-05-08 |
| Model Number | 79-81135 |
| Catalog Number | 79-81135 |
| Lot Number | NI |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 89227 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 2985 SCOTT ST. VISTA CA 92083 US |
| Baseline Brand Name | MED/SURG SHOE; SIZE: 42/45, M |
| Baseline Generic Name | POST-OP SHOE |
| Baseline Model No | 79-81135 |
| Baseline Catalog No | 79-81135 |
| Baseline ID | NA |
| Baseline Device Family | MED/SURG SHOE |
| 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 | 1. Required No Informationntervention | 1997-05-08 |
| 2 | 0 | 1997-05-08 |