MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-13 for SMART SEAT UNK manufactured by Comfort Co..
[17767823]
Support pieces of drop seat cracked while resident was seated in wheelchair. Resortive dept nurses discovered upon re-assessment of drop seat appropriateness. No injury occurred. Drop seat removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018668 |
| MDR Report Key | 273655 |
| Date Received | 2000-04-13 |
| Date of Report | 2000-04-04 |
| Date of Event | 2000-03-01 |
| Date Added to Maude | 2000-04-18 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART SEAT |
| Generic Name | DROP SEAT FOR WHEELCHAIR |
| Product Code | KNO |
| Date Received | 2000-04-13 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | ITEM#00046-00 DIS DIRECT SUPPL |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 264901 |
| Manufacturer | COMFORT CO. |
| Manufacturer Address | 2025 SO. BLACK ST. BOZEMAN MT 59715 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-04-13 |