MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-11 for BUNNYLINE 05001-01 manufactured by Dillon Orthopedics.
[21080657]
The bunny boot was applied to prevent foot drop. Patient developed numerous dark blue lesions on one heel and an erthematous area on the otherdevice labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3552 |
| MDR Report Key | 3552 |
| Date Received | 1992-12-11 |
| Date of Report | 1992-12-11 |
| Date of Event | 1992-07-31 |
| Date Facility Aware | 1992-08-05 |
| Report Date | 1992-12-11 |
| Date Reported to Mfgr | 1992-08-11 |
| Date Added to Maude | 1993-04-23 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUNNYLINE |
| Generic Name | BUNNY BOOT |
| Product Code | IPG |
| Date Received | 1992-12-11 |
| Catalog Number | 05001-01 |
| ID Number | A083629 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Device Age | 01-APR-91 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 3294 |
| Manufacturer | DILLON ORTHOPEDICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-12-11 |