MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-16 for DRIVE MEDICAL 15001ABV manufactured by Shanghai Shunlong Physical Therapy Equipment Co.,.
[67599530]
Drive devilbiss healthcare received noticed regarding the incident from the enduser's daughter, involving a bed rail, a product imported and distributed by drive devilbiss healthcare. While the enduser was in the bed, she allegedly fell out of the bed and sustained a compression fracture of the spine. The bed rail was down at the time of the incident because it allegedly didn't fit into the receiver. Drive devilbiss healthcare is in the process of getting the product back to further the investigation. This report is based on the information that was provided by the enduser's daughter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00015 |
| MDR Report Key | 6336302 |
| Date Received | 2017-02-16 |
| Date of Report | 2017-01-18 |
| Date Facility Aware | 2017-01-18 |
| Report Date | 2017-02-15 |
| Date Reported to FDA | 2017-02-15 |
| Date Reported to Mfgr | 2017-02-15 |
| Date Added to Maude | 2017-02-16 |
| 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 | DRIVE MEDICAL |
| Generic Name | BED, MANUAL |
| Product Code | FNJ |
| Date Received | 2017-02-16 |
| Model Number | 15001ABV |
| 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 | SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., |
| Manufacturer Address | NO. 259 JIUGAN ROAD SIJING TWN, SONG JIANG DISTR. SHANGHAI SHANGHAI, 201601 CH 201601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-16 |