MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-08 for MEDICHOICE BARIATRIC XD WHEELCHAIR 2867WCBAR26E manufactured by Zhongshan A&j Medical Equipment Co., Ltd.
[144544975]
.
Patient Sequence No: 1, Text Type: N, H10
[144544976]
A cna and patient's daughter were assisting the patient into a bariatric xd wheelchair (650 lb. Weight capacity). Apparently the wheelchair was not fully extended, and locked into an open position. The patient positioned herself into the chair by holding on to the edge of the wheelchair seat. Upon applying her weight to the seat, the chair fully extended and opened, and the patient's small finger was caught between the seat support tube and the underneath cradle. The distal tip of the phalanx, left small finger, was noted to be amputated and bleeding. The patient was taken into surgery for a reattachment of the distal tip. The patient was re-admitted to the hospital and upon release was to follow-up with her primary care physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428983-2019-00002 |
| MDR Report Key | 8592876 |
| Date Received | 2019-05-08 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-04-10 |
| Date Facility Aware | 2019-04-15 |
| Report Date | 2019-05-08 |
| Date Reported to FDA | 2019-05-08 |
| Date Reported to Mfgr | 2019-05-07 |
| Date Added to Maude | 2019-05-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MEDICHOICE BARIATRIC XD WHEELCHAIR |
| Generic Name | BARIATRIC XD WHEELCHAIR |
| Product Code | IOR |
| Date Received | 2019-05-08 |
| Model Number | 2867WCBAR26E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD |
| Manufacturer Address | ZHONGSHAN, GUANDONG CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-08 |