MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-20 for SINGLE PATIENT USE GAIT BELT 6556 manufactured by Posey Product Llc.
[78146192]
(b)(4). Historical data found similar results of "slippage", however the reported issue could not be confirmed. Internal investigations found the device functions as expected and does not slip if all the application instructions are followed. At this time there is no evidence that a manufacturing non-conformity contributed to the reported issue, 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. The ifu states: "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. " 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. (b)(4). Product will not be returned.
Patient Sequence No: 1, Text Type: N, H10
[78146193]
Customer reported the gait belt becomes loose when in use with a patient. The gait belt is no longer snug. The date the issue was discovered is unknown and no patient injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2017-00031 |
| MDR Report Key | 6655923 |
| Date Received | 2017-06-20 |
| Date of Report | 2017-05-26 |
| Date Mfgr Received | 2017-05-26 |
| Date Added to Maude | 2017-06-20 |
| 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 | PHYSICAL THERAPIST |
| 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 | SINGLE PATIENT USE GAIT BELT |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2017-06-20 |
| Model Number | 6556 |
| Catalog Number | 6556 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCT LLC |
| Manufacturer Address | 5635 PECK RD. ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-20 |