MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-31 for QUICK-RELEASE TWICE-AS-TOUGH CUFFS 2791Q manufactured by Posey Products Llc.
[146783142]
Customer declined to return device. Historical review of the complaint database found 4 other event with similar issue where the patients were able to release from the restraint. Of the 4 complaints, product was returned for two of the complaints. In both instances, the product was not being used per the instructions for use (ifu). Analysis of one device found it to have a box stitch that was sewn with a high amount of tension that had failed over time, possibly due to incorrect sewing machine settings. There was no patient injury involved in any of the complaints. Sample evaluation found no evidence of manufacturing concern and historical review does not show a trend of product malfunction. The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. It is recommended that the restraint not be used on patient who is or becomes highly aggressive, combative, agitated or suicidal. The ifu also provided extra warning to always monitor patient per facility policy. Be aware that constant monitoring may be required for: aggressive or agitated patients; and patients deemed at risk of aspirating their vomit. This includes patients in the supine position, or who are not able to sit up. If the patient vomits, he or she could aspirate the vomit and suffocate. Be prepared to intervene at the first sign of danger. Such patients require frequent review and evaluation of their physical and psychological status. Without return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be reviewed. 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 warnings 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 warranted. Manufacturer reference file # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146783143]
Customer reported while the patient is in use with the restraint the patient is able to release themselves from the restraint. 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 | 2020362-2019-00133 |
| MDR Report Key | 8660683 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-01 |
| Date Mfgr Received | 2019-05-01 |
| Date Added to Maude | 2019-05-31 |
| 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 | QUICK-RELEASE TWICE-AS-TOUGH CUFFS |
| Generic Name | RESTRAINT, PROTECTIVE |
| Product Code | FMQ |
| Date Received | 2019-05-31 |
| Model Number | 2791Q |
| Catalog Number | 2791Q |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-31 |