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 2814 manufactured by Posey Products Llc.
[139329322]
Customer confirmed product had been discarded. Therefore, this event is reported solely on the information provided by the customer. A review of the historical database did not find any other complaints related to the use of this material in our products 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 warning 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 the failure mode will assessed, documented and acted upon as warrant. Manufacturer reference file #(b)(4). Product will not be returning.
Patient Sequence No: 1, Text Type: N, H10
[139329323]
Customer reported the nurses are complaining of patient skin issues that they believe may be related to the material change that was made to the sheepskin type fur at the wrist. Additional information received on 2019/02/21 stated the customer was prone to skin breakdown and developed a skin tear during use of the mitt. Blood was found on the edges of the mitt and the patient's wound was dressed by the nurse. The date the issue was discovered is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2019-00044 |
| MDR Report Key | 8436521 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-20 |
| Date of Report | 2019-02-21 |
| Date Mfgr Received | 2019-02-21 |
| 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 | 2814 |
| Catalog Number | 2814 |
| 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. Required No Informationntervention | 2019-03-20 |