MAUDE Adverse Event Report: TIDI PRODUCTS LLC SAFETY VEST; RESTRAINT, PROTECTIVE

Model Number	3060M
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer is reporting a complaint on product # 3060m.The customer states that patient can unbuckle the roll vests by themselves.This has taken place in multiple instances.Likely they will not be sending the product back.
Additional Manufacturer Narrative
H3: customer confirmed the product will not be returning for analysis.Therefore, this event is reported based on the information provided by the customer.Without the return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be confirmed.A review of the complaint database did not reveal any similar events against this issue in the past two years.Therefore, it appears this complaint was an isolated event.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 warns 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.Dispose of damaged products per facility policy for biohazardous material.Contraindications: do not use on a patient who is or becomes highly aggressive, combative, agitated, or suicidal.Without return of the device the reported issue could not be confirmed.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.Therefore, no further 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 2023-01224.H3 other text : product not returned.

• Brand Name: SAFETY VEST
• Common Device Name: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 18097202
• Report Number: 2182318-2023-00105
• Device Sequence Number: 14967737
• Product Code: FMQ
• UDI-Device Identifier: 10190676002600
• UDI-Public: 10190676002600
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K963442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3060M
• Device Catalogue Number: 3060M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown