MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-11 for MITTS- NO FINGER SEPARATORS 2811 manufactured by Posey Products Llc.
[141563445]
The customer confirmed they will not be returning the device. This event is reported solely on the information provided by the customer. Historical review of the complaint database found 4 other event with similar issue where the patients were able to maneuver around the mitts. Of the 4 complaints, product was returned for only one of the complaint. Analysis of the device found it to have met specifications and functioned as designed. 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). Product will not be returning.
Patient Sequence No: 1, Text Type: N, H10
[141563446]
Customer reported patient was able to remove the mitts resulting in unplanned self-extubation. Additional information from the customer stated she do not believe the issue is related to any specific product failure. The date the issue was discovered is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00080 |
| MDR Report Key | 8502389 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-11 |
| Date of Report | 2019-03-18 |
| Date Mfgr Received | 2019-03-18 |
| Date Added to Maude | 2019-04-11 |
| 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 | MITTS- NO FINGER SEPARATORS |
| Generic Name | RESTRAINT, PROTECTIVE |
| Product Code | FMQ |
| Date Received | 2019-04-11 |
| Model Number | 2811 |
| Catalog Number | 2811 |
| 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 | 1. Other | 2019-04-11 |