MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for TRANSFER BELT, QUICK-RELEASE ECONOMY 6537Q manufactured by Posey Products Llc.
[97947710]
Product has been received but evaluation of the device was not completed at the time of this report. This report is based solely on the information provided by the customer. An investigation of similar events found that broken buckles were a result of wear and tear. Of those returned, the product was over 48 months old. There was no serious injury reported in any of the cases. Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. 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. " at this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint. 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).
Patient Sequence No: 1, Text Type: N, H10
[97950091]
Customer reported while transferring her father from the wheelchair to the bed, the buckle snapped and both the patient and caregiver fell. Neither suffered any injuries. Customer reported having the belt for a few years and did not report the date the incident occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2018-00001 |
| MDR Report Key | 7208537 |
| Date Received | 2018-01-19 |
| Date of Report | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2014-07-03 |
| Date Added to Maude | 2018-01-19 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRANSFER BELT, QUICK-RELEASE ECONOMY |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2018-01-19 |
| Model Number | 6537Q |
| Catalog Number | 6537Q |
| Lot Number | 4184T107 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | Y |
| 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 RD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-19 |