MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-06 for METAL BUCKLE GAIT BELT, STANDARD WHITE 6524 manufactured by Posey Products Llc.
[85377211]
This report is based solely on a product review and no incidents were reported. If the buckle(s) pre-releases or is backwards, the complaint is reportable. These conditions may allow the buckle to initially close but it is possible that the buckle could later unlatch while in use. The instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. The application instructions caution the user to always inspect before each use: check for broken stitches or parts; torn, cut or frayed material; or buckles that are cracked or broken and do not hold securely. Never use soiled or damaged products. At this time there is no evidence that a manufacturing nonconformity 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 at this time. (b)(4). Device not available. Customer review.
Patient Sequence No: 1, Text Type: N, H10
[85377212]
Post market surveillance search on (b)(6) found several reports about the posey gait belts: buckle was sewn on wrong, the quick release buckle does not hold when tightened. The date these issue were discovered is unknown and no incidents or injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2017-00064 |
| MDR Report Key | 6845380 |
| Date Received | 2017-09-06 |
| Date of Report | 2017-08-14 |
| Date Mfgr Received | 2017-08-14 |
| Date Added to Maude | 2017-09-06 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM HINCY |
| Manufacturer Street | POSEY PRODUCTS LLC 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 | METAL BUCKLE GAIT BELT, STANDARD WHITE |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2017-09-06 |
| Model Number | 6524 |
| Catalog Number | 6524 |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-06 |