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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TIDI PRODUCTS MESH PEEK A BOO MITT RESTRAINT, PROTECTIVE

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TIDI PRODUCTS MESH PEEK A BOO MITT RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2825
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Customer contacted tm via email to report incident. Patient was able to turn their hand around inside the mitt and dislodge an internal tub. Ifu was followed as written. No injuries occurred. No gtin number provided.
 
Manufacturer Narrative
This report is based solely on the information provided by the customer. Confirmation of the customer's complaint and the root cause could not be determined without the return of the product. Historical review of the complaint database did not reveal any similar events against part 2825 where the patient was able to maneuver around the mitts to remove tubes. The customer has confirmed they switched back to the previously used posey mitt with padding on both sides of the mitt. Customer determined the mesh mitts were not safe with their patient population. The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device. The ifu states, never alter or repair this product. Always inspect before each use: check for broken stitches or parts; torn, cut or frayed material; or locks, buckles, or hook-and-loop fasteners that do not hold securely. Do not use soiled or damaged products. Doing so may result in serious injury or death. Do not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, is deemed to be an immediate risk to themselves or to others. 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 not returned.
 
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Brand NameMESH PEEK A BOO MITT
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 Key14847587
MDR Text Key298307779
Report Number2182318-2022-00068
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 05/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number2825
Device Catalogue Number2825
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/31/2022
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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