MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for ACCULOC GAIT BELT manufactured by Unknown.
[176460819]
Gait belt on patient by physical therapy. Pt attempted to help patient using the gait belt. As the patient was beginning to stand, the gait belt slid open and will not stay tight on patient. Patient was unharmed and did not fall. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092460 |
| MDR Report Key | 9622949 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-17 |
| Date of Event | 2020-01-17 |
| Date Added to Maude | 2020-01-23 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | ACCULOC GAIT BELT |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2020-01-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |