MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-01 for QUICK-RELEASE GAIT BELT, STANDARD NAVY (BARIATRIC) 6528QL manufactured by Posey Products Llc.
[101512344]
Product is scheduled to be returned but has not been received in by manufacturer at the time of this report. Therefore, this report is based solely on the information provided by the customer. At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. Manufacturer reference file (b)(4). No product returned at this time.
Patient Sequence No: 1, Text Type: N, H10
[101512345]
Customer reported when he went to release the gait belt from the patient, he noticed one of the prongs was missing from the male portion of the belt. The date the issue was discovered is unknown. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00013 |
| MDR Report Key | 7308578 |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-26 |
| Date Mfgr Received | 2018-03-09 |
| Device Manufacturer Date | 2014-11-12 |
| Date Added to Maude | 2018-03-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM HINCY |
| Manufacturer Street | POSEY COMPANY 5635 PECK ROAD |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | QUICK-RELEASE GAIT BELT, STANDARD NAVY (BARIATRIC) |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2018-03-01 |
| Model Number | 6528QL |
| Catalog Number | 6528QL |
| Lot Number | 4316T024 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK ROAD ARCADIA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-01 |