MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-16 for RED DOT CRUTCH 6951 91-214 manufactured by Guardian.
[19147428]
Locking mechanism on crutch handgrip dislodged while patient was ambulating causing one side of the handgrip to depress approximately one (1) inch. Patient states that she lost balance and fell. Device not labeled for single use. Patient medical status prior to event: invalid data. There was not 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: no data. Results of evaluation: no data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device recalled by manufacturer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902 |
| MDR Report Key | 9902 |
| Date Received | 1994-09-16 |
| Date of Report | 1994-09-07 |
| Date of Event | 1994-04-05 |
| Date Facility Aware | 1994-04-05 |
| Report Date | 1994-09-07 |
| Date Reported to Mfgr | 1994-04-06 |
| Date Added to Maude | 1995-02-10 |
| 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 | RED DOT CRUTCH |
| Generic Name | CRUTCHES |
| Product Code | IMZ |
| Date Received | 1994-09-16 |
| Model Number | 6951 |
| Catalog Number | 91-214 |
| Lot Number | 940303 |
| ID Number | N/A |
| Operator | OTHER CAREGIVERS |
| Device Availability | N |
| Device Age | 01-MAR-94 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 9554 |
| Manufacturer | GUARDIAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-09-16 |