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 |