MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-08 for FOAM LIMB HOLDER 2532 manufactured by Posey Products Llc.
[142089106]
Evaluation results: evaluation of the returned device found the bed connecting strap was threaded incorrectly into the male buckle, and it appears to be stretched or worn. The worn area of the bed connecting strap will slip when pulled at an angle. The issue has been addressed internally via corrective action. 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
[142089107]
Customer reported the teeth appear to be correct, but the strap is not holding. The date the issue was discovered is unknown and no patient incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00067 |
| MDR Report Key | 8491822 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-14 |
| Date Mfgr Received | 2019-03-14 |
| Device Manufacturer Date | 2018-12-13 |
| Date Added to Maude | 2019-04-08 |
| 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 | 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 | 3 |
| Brand Name | FOAM LIMB HOLDER |
| Generic Name | RESTRAINT, PROTECTIVE |
| Product Code | FMQ |
| Date Received | 2019-04-08 |
| Returned To Mfg | 2019-03-27 |
| Model Number | 2532 |
| Catalog Number | 2532 |
| Lot Number | 8347T065 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-08 |