MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-17 for BODY ARMOR WALKER HI * manufactured by Darco Int'l, Inc..
[17171867]
Pt diagnosed with tear in achilles tendon. The pt received a boot cast at dr's office. Nine days later, the boot cast broke while the pt was wearing it. The plastic broke at the ankle buckle on the right side of the boot. On the left side, the leg support separated from the foot support. The buckle at the ankle would not stay closed. The pt was sitting in a chair and moving foot when the boot cast broke. Prior to this, there was no physical damage to the boot cast. The pt returned the boot cast to dr five days later. The dr's staff said the boot cast would be returned to the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023133 |
| MDR Report Key | 356503 |
| Date Received | 2001-10-17 |
| Date of Report | 2001-10-17 |
| Date of Event | 2001-10-11 |
| Date Added to Maude | 2001-10-22 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | BODY ARMOR WALKER HI |
| Generic Name | BOOT CAST |
| Product Code | IPG |
| Date Received | 2001-10-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | UPC: 6 09271 13935 0 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 345730 |
| Manufacturer | DARCO INT'L, INC. |
| Manufacturer Address | 1327 7TH AVE HUNTINGTON WV 25701 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-10-17 |