MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-13 for GAIT BELT DYKF1045 manufactured by Medline Industries, Inc.
[120121062]
The gait belt clasp came undone while staff were assisting patient to stand from chair. The clasp unbuckled, patient's knees buckled, and staff lowered patient to the floor. The rn checked another gait belt in the fall bags, and noted it too did not stay closed when staff pulled on it. Manufacturer response for gait belt, (brand not provided) (per site reporter). Medline has verified that a batch of gait belts were not made to specification. They have taken immediate action to source a domestic product and have put it into our fall bundles.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7872094 |
| MDR Report Key | 7872094 |
| Date Received | 2018-09-13 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-09-07 |
| Report Date | 2018-09-10 |
| Date Reported to FDA | 2018-09-10 |
| Date Reported to Mfgr | 2018-09-13 |
| Date Added to Maude | 2018-09-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | GAIT BELT |
| Generic Name | TRANSFER AID |
| Product Code | IKX |
| Date Received | 2018-09-13 |
| Model Number | DYKF1045 |
| Catalog Number | DYKF1045 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-13 |