MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-12-22 for SINGLE PATIENT GAIT BELT LONG 6556L manufactured by Jt Posey Co..
[63185588]
Product was requested to be returned for evaluation and has not been received. The report is based solely on the customer's reported issue. The instructions for use state "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. " (b)(4). Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[63185589]
Customer reported the gait belt buckle (teeth) are not long/sharp enough to penetrate the belt to provide a good hold or the fabric is too tightly woven for the teeth to penetrate to provide a good hold. No patient/care giver incident or injury was reported and the date the issue was discovered is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2016-00050 |
| MDR Report Key | 6201482 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-01 |
| Date Mfgr Received | 2016-12-01 |
| Date Added to Maude | 2016-12-22 |
| 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 | 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 | 3 |
| Brand Name | SINGLE PATIENT GAIT BELT LONG |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2016-12-22 |
| Model Number | 6556L |
| Catalog Number | 6556L |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JT POSEY CO. |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 910060020 US 910060020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-22 |