MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-20 for MITTS - NO FINGER SEPARATORS 2819 manufactured by Posey Products Llc.
[139379098]
Customer confirmed the product will not be returning, therefore, this report is based solely on the information provided by the customer. Ongoing investigation is underway and results of investigation will be provided at a later time. Manufacturer reference file # (b)(4). Product will not be returning.
Patient Sequence No: 1, Text Type: N, H10
[139379099]
Customer reported the patient is able to remove their iv's by grasping the items using their thumb and index finger customer reported there is too much room in the mitt where the patient is able to maneuver their fingers. The date the issue was discovered is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00048 |
| MDR Report Key | 8438065 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-20 |
| Date of Report | 2019-02-22 |
| Date Mfgr Received | 2019-02-22 |
| Date Added to Maude | 2019-03-20 |
| 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 | 2019-03-20 |
| Model Number | 2819 |
| Catalog Number | 2819 |
| Device Availability | * |
| 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 | 1. Required No Informationntervention | 2019-03-20 |