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U.S. Department of Health and Human Services

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

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TIDI PRODUCTS MITTS - NO FINGER SEPARATORS RESTRAINT, PROTECTIVE Back to Search Results
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).
 
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Brand NameMITTS - NO FINGER SEPARATORS
Type of DeviceRESTRAINT, 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 Key14207150
MDR Text Key290070678
Report Number2182318-2022-00033
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number2810
Device Catalogue Number2810
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2022
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 Unkown

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