MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-03-26 for CONNECTED ANKLE TWICE-AS-TOUGH CUFFS 2797 manufactured by Posey Products Llc.
[139988568]
Product return is expected but have not been received in yet. Therefore, this report is based solely on the information provided 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 (ifu) 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). Expected but have not returned yet.
Patient Sequence No: 1, Text Type: N, H10
[139988569]
Customer reported a teenage patient was physically restrained to a stretcher for aggression and agitation and the webbing part of the ankle restraint broke. Additional information from the customer on 03/25/2019 confirmed there was no serious injury associated with the reported failure. The date the issue was discovered is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00056 |
| MDR Report Key | 8453151 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-05 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2018-09-20 |
| Date Added to Maude | 2019-03-26 |
| 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 | CONNECTED ANKLE TWICE-AS-TOUGH CUFFS |
| Generic Name | RESTRAINT, PROTECTIVE |
| Product Code | FMQ |
| Date Received | 2019-03-26 |
| Model Number | 2797 |
| Catalog Number | 2797 |
| Lot Number | 8263T079 |
| 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 RD ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-26 |