MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-05-13 for CANVAS ROCKER CAST & SANDAL, LARGE * 2035-04 manufactured by Deroyal Industries, Inc..
[96797]
The toe strap stitching of the cast shoe detached while a pt was wearing deroyal case shoe with a short walking cast. The pt fell, dislocating her shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037420-1998-00001 |
| MDR Report Key | 167687 |
| Report Source | 06 |
| Date Received | 1998-05-13 |
| Date of Report | 1998-05-12 |
| Date of Event | 1998-04-13 |
| Date Facility Aware | 1998-04-13 |
| Date Mfgr Received | 1998-04-13 |
| Date Added to Maude | 1998-05-19 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANVAS ROCKER CAST & SANDAL, LARGE |
| Generic Name | CAST SHOE |
| Product Code | FXW |
| Date Received | 1998-05-13 |
| Returned To Mfg | 1998-04-28 |
| Model Number | * |
| Catalog Number | 2035-04 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 163159 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | CANVAS ROCKER CAST & SANDAL, LARGE |
| Baseline Generic Name | CAST SHOE |
| Baseline Model No | * |
| Baseline Catalog No | 2035-04 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-05-13 |