MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for POSEY 2799 manufactured by Posey Company.
[105562554]
Psychiatric pt placed in restraints for violent behavior. Restraints detached and were noted to come unsewn releasing the restraint from the bed allowing pt to become free of the restraint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076464 |
| MDR Report Key | 7428428 |
| Date Received | 2018-04-12 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-02-07 |
| Date Added to Maude | 2018-04-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POSEY |
| Generic Name | TWICE AS TOUGH CUFFS - KEY LOCK |
| Product Code | OYS |
| Date Received | 2018-04-12 |
| Model Number | 2799 |
| Lot Number | 6242T038 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POSEY COMPANY |
| Manufacturer Address | 5635 PEK ROAD ARCADIA CA 910060020 US 910060020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-04-12 |