MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-02 for FOAM LIMB HOLDER 2532 manufactured by Posey Products Llc.
[140654524]
Evaluation results: evaluation of the returned device found the male buckle component at the bed connecting strap, on a single returned limb holder, was installed backward causing the bed connecting strap to slip when pulled. All buckles were compared to the product drawing and product sample. The male buckle installed incorrectly is a known issue related to documentation guiding the manufacturing process. The issue has been addressed internally via corrective action. Samples taken from multiple lots, at multiple facilities, found no other instances of incorrectly installed male buckles. 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 warrant. Manufacturer reference file# (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140654525]
Customer reported that the wrist restraint does not restrain the patient and that they recently had a patient self-extubate. The customer stated that it appears to be that the clip on the unit was installed backwards. The date the issue was discovered is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00063 |
| MDR Report Key | 8474614 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-02 |
| Date of Report | 2019-03-05 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2019-01-21 |
| Date Added to Maude | 2019-04-02 |
| 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 |
| Remedial Action | IN |
| 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 | 2019-04-02 |
| Model Number | 2532 |
| Catalog Number | 2532 |
| Lot Number | 9021T147 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY PRODUCTS LLC |
| Manufacturer Address | 5635 PECK RD. ARCADIA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-02 |