MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-05 for SMITH & RICHARDS UNK manufactured by Smith & Nephew Richards.
[49124]
Pt placed in bucks traction splint/boot. The inner seam "bowed" or "coned" into the heel creating a 1 inch heel decubitus found by pt. Size medium l.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 78162 |
| MDR Report Key | 78162 |
| Date Received | 1996-11-05 |
| Date of Report | 1996-03-25 |
| Date of Event | 1996-03-15 |
| Date Added to Maude | 1997-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITH & RICHARDS |
| Generic Name | BUCKS TRACTION SPLINT/BOOT |
| Product Code | HSP |
| Date Received | 1996-11-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 77798 |
| Manufacturer | SMITH & NEPHEW RICHARDS |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-11-05 |