MAUDE Adverse Event Report: TIDI PRODUCTS MITTS - NO FINGER SEPARATORS; RESTRAINT, PROTECTIVE

Model Number 2810

Device Problem Material Integrity Problem (2978)

Patient Problem Abrasion (1689)

Event Type  malfunction  

Event Description

Tm reporting facility advised patient had skin breakdown reported on hand.Suggested the hand mitt may have contributed to skin issue.There is no sample of item used.The date the issue was discovered is unknown and no patient incident or injury was reported.

Manufacturer Narrative

Customer confirmed product had been discarded.Therefore, this event is reported based on the information provided by the customer.A review of the complaint database did not reveal any similar events against this issue.Therefore, it appears this complaint was an isolated event.The instruction for use (ifu) states: monitor per facility policy.Check to ensure that: mitts are properly secured.If applied too tightly, circulation will be restricted; if applied too loosely, the patient may be able to slip his or her limb from the device; mitts are intact, not torn or damaged, and hook and loop closes securely.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).

• Brand Name: MITTS - NO FINGER SEPARATORS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 14207150
• MDR Text Key: 290070678
• Report Number: 2182318-2022-00033
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2810
• Device Catalogue Number: 2810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1