MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-05 for EVERYDAY ESSENTIALS DELUXE GAIT BELT P2500 manufactured by Dongguan China Effort Healthcare Products Co..
[30549917]
Patient's spouse was attempting to lift patient when he maintains that the gait belt changed position and the buckle released. The patient fell forward onto the floor striking her head. She required 8 stitched to close the wound. She also sprained her left wrist and dislocated an elbow in the fall. Subject device was tested and did not malfunction during multiple tests.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2015-00024 |
| MDR Report Key | 5205450 |
| Date Received | 2015-11-05 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-10-04 |
| Date Facility Aware | 2015-10-13 |
| Report Date | 2015-11-05 |
| Date Reported to FDA | 2015-11-05 |
| Date Reported to Mfgr | 2015-11-05 |
| Date Added to Maude | 2015-11-05 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | EVERYDAY ESSENTIALS DELUXE GAIT BELT |
| Generic Name | GAIT BELT |
| Product Code | ISR |
| Date Received | 2015-11-05 |
| Model Number | P2500 |
| Catalog Number | P2500 |
| Lot Number | N/A |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | Y |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DONGGUAN CHINA EFFORT HEALTHCARE PRODUCTS CO. |
| Manufacturer Address | 17 QUKING 2ND ROAD, QUANTANG VILLAGE, LIAOBU TOWN DONGGUAN CITY, GUANGDONG 523425 CH 523425 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-05 |