MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-01 for FOAM LIMB HOLDER 2532 manufactured by .
[140628913]
Product was received in and damages to the buckle was confirmed. However, the investigation is ongoing for the root cause. Therefore, this report is based on the information reported by the customer. At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device. 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 warrant. Manufacturer reference file #(b)(4). Evaluation started but not completed.
Patient Sequence No: 1, Text Type: N, H10
[140628914]
Customer reported the quick release limb holder broke resulting in a patient attempting to get out of the bed and falling. The date the issue was discovered is unknown and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00051 |
| MDR Report Key | 8471809 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-01 |
| Date of Report | 2019-03-04 |
| Date Mfgr Received | 2019-05-09 |
| Device Manufacturer Date | 2018-07-05 |
| Date Added to Maude | 2019-04-01 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOAM LIMB HOLDER |
| Generic Name | RESTRAINT, PROTECTIVE |
| Product Code | FMQ |
| Date Received | 2019-04-01 |
| Returned To Mfg | 2019-03-11 |
| Model Number | 2532 |
| Catalog Number | 2532 |
| Lot Number | 8332T186 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-01 |