MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-12 for CONNECTED ANKLE TWICE-AS-TOUGH CUFFS 2797 manufactured by Posey Products Llc.
[138506689]
Reference associated manufacturing report number 2020362-2019-00035. Customer confirmed the product will not be returning for analysis. Therefore, this event is reported based on the information provided by the customer and from historical data of similar complaint. Sample and complaint recreation confirmed the reported issue. As such, ongoing investigation is underway to determine the root cause. Manufacturing reference file #(b)(4). Product will not be returning.
Patient Sequence No: 1, Text Type: N, H10
[138506690]
The customer reported the strap is slipping through the d-ring attachment. As a result while the patient was still restrained within the cuffs the patient was allowed enough room to reach out and bite an employee. The employee was provided medical treatment for the bite. Customer stated this occurred in (b)(6) of 2019 but could not recall the exact date. The date the issue was discovered is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00034 |
| MDR Report Key | 8410926 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-12 |
| Date of Report | 2019-04-12 |
| Date Mfgr Received | 2019-02-18 |
| Date Added to Maude | 2019-03-12 |
| 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 |
| Remedial Action | RC |
| 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 | 2019-03-12 |
| Model Number | 2797 |
| Catalog Number | 2797 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2019-03-12 |