MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for DRIVE 15300BV-PKG manufactured by Shanghai Shunlong Physical Therapy Equipment Co.,..
[144327065]
(b)(4) is the initial importer of the device which is a bed. The weld broke and the frame came loose from the headboard. The bed slid into the wall causing the occupant to hit her head. The headboard then feel forward on top of her. Incident exacerbated her rheumatoid arthritis. Patient has heat applied to her back before sleep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00023 |
| MDR Report Key | 8588159 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-03-19 |
| Date Facility Aware | 2019-04-10 |
| Report Date | 2019-05-07 |
| Date Reported to FDA | 2019-05-07 |
| Date Reported to Mfgr | 2019-05-07 |
| Date Added to Maude | 2019-05-07 |
| 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 |
| 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 | DRIVE |
| Generic Name | BED BARIATRIC |
| Product Code | OSI |
| Date Received | 2019-05-07 |
| Model Number | 15300BV-PKG |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 21 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.,. |
| Manufacturer Address | NO. 259 JIUGAN ROAD SIJING TOWN SONG JIANG DISTRICT, SHANGHAI, CHINA 201601 CH 201601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-07 |