MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-22 for SADDLE ABDUCTER WEDGE, BRACE LATERAL AND PELVIC POSITIONER N/I manufactured by Health Care Provider, Inc..
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Resident using seating device tipped foward causing laceration on forehead which resuired suturesdevice labeled for single use. Patient medical status prior to event: fair condition. 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. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, other, other, invalid data. Results of evaluation: other. Conclusion: other. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device use continued with restrictions/limitations, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1092 |
| MDR Report Key | 1092 |
| Date Received | 1992-07-22 |
| Date of Event | 1992-03-13 |
| Date Facility Aware | 1992-03-13 |
| Date Reported to Mfgr | 1992-03-20 |
| Date Added to Maude | 1992-08-20 |
| 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 | SADDLE ABDUCTER WEDGE, BRACE LATERAL AND PELVIC POSITIONER |
| Generic Name | SAME AS ABOVE |
| Product Code | ITC |
| Date Received | 1992-07-22 |
| Model Number | N/I |
| Catalog Number | N/I |
| Lot Number | N/I |
| ID Number | N/I |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 01-JAN-92 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1046 |
| Manufacturer | HEALTH CARE PROVIDER, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-22 |