MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-30 for CAREX TRANSPORT CHAIR FGA22600 0000 manufactured by Mass Corporation/maxhealth.
[29973246]
Called in requesting a left back handle for the a226. Care giver put wife in the car in the transport chair and took a corner and wife fell over backwards in the chair and ended up in the emergency room. Caller said it was no fault of the chair was the negligence of care giver not to strap her in. Chair is only 1 mos old.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182780-2015-00018 |
| MDR Report Key | 5192017 |
| Date Received | 2015-10-30 |
| Date of Report | 2015-10-30 |
| Date of Event | 2015-09-27 |
| Date Facility Aware | 2015-09-30 |
| Report Date | 2015-10-30 |
| Date Reported to FDA | 2015-10-30 |
| Date Reported to Mfgr | 2015-10-30 |
| Date Added to Maude | 2015-10-30 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | CAREX TRANSPORT CHAIR |
| Generic Name | TRANSPORT CHAIR |
| Product Code | INM |
| Date Received | 2015-10-30 |
| Model Number | FGA22600 0000 |
| Catalog Number | FGA22600 0000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASS CORPORATION/MAXHEALTH |
| Manufacturer Address | 15F-6, NO.81, SEC. 1, HSIN TAI TAIWAN, HSI CHIH, TAIPEI HSIEN TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-30 |