MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for DRIVE 16500BV manufactured by Combo (zhong Shan) Medical Equipment Co.,ltd..
[142034565]
(b)(6) is the initial importer of the device which is a bed rail. We are awaiting return of the device for evaluation. It is not believed that the device failed. The end user was trying to lower the rails from inside the bed and the rails got stuck. While reaching over she got her leg caught in the rail. She cut, right calf. Which required 29 stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00019 |
| MDR Report Key | 8516221 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-03-14 |
| Date Facility Aware | 2019-04-05 |
| Report Date | 2019-04-15 |
| Date Reported to FDA | 2019-04-15 |
| Date Reported to Mfgr | 2019-04-15 |
| Date Added to Maude | 2019-04-15 |
| 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 RAIL |
| Product Code | FNJ |
| Date Received | 2019-04-15 |
| Model Number | 16500BV |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. |
| Manufacturer Address | 6 TONGXING EAST RD DONGSHENG TOWN ZHONGSHAN CITY, GUANGDONG 528414 CH 528414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-15 |