MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-22 for CONNECTED TWICE-AS-TOUGH CUFFS 2794 manufactured by Posey Products Llc.
[139705666]
Customer confirmed the product was discarded and they will not be returning. Therefore, this complaint is based solely on the customer reported issue. Additional customer feedback is currently pending. 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. Instructions for use indicate; not to use this device on a patient who is or becomes; highly aggressive or combative; self-destructive; or deemed to be an immediate risk to others, unless the patient is under constant supervision. Instructions for use also indicate; severe psychological, or physical problems may occur: if the applied device is uncomfortable; or if it severely limits movement. If the patient is likely to cause injury to him/herself or others, get help from a qualified medical authority to find alternate intervention or method of restraint. 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). Product was discarded.
Patient Sequence No: 1, Text Type: N, H10
[139705667]
Customer reported an adolescent patient somehow got her arms behind her back and above her head. The nurse attempted to reapply the restraint and a spring on the lock broke free and would not re-lock. The patient was not injured but the nurse was injured. The extent of the nurse's injury is currently unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00049 |
| MDR Report Key | 8446464 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-22 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-02-24 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-03-22 |
| 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 TWICE-AS-TOUGH CUFFS |
| Generic Name | RESTRAINT, PROTECTIVE |
| Product Code | FMQ |
| Date Received | 2019-03-22 |
| Model Number | 2794 |
| Catalog Number | 2794 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-03-22 |