MAUDE Adverse Event Report: TIDI PRODUCTS LLC CHILD LIMB HOLDERS; RESTRAINT, PROTECTIVE

Model Number	4734
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 the product is scheduled to be returned but has not been received in by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.A review of the complaint database for parts 4733 and 4734 did not reveal any similar events against this issue in the past five years.Therefore, it appears this complaint was an isolated event.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.Dispose of damaged products per facility policy for biohazardous material.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.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.Manufacture reference file 2023-01250 h3 other text : product not returned.
Event or Problem Description
Customer reported a complaint via email stating they have noticed that the velcro on the new infant med-surg restraints is not very strong.They have found they have to massage the velcro to get it to adhere, but then after securing a couple of times, even with massaging the velcro, it does not adhere very well.

• Brand Name: CHILD LIMB HOLDERS
• 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: 18131951
• Report Number: 2182318-2023-00107
• Device Sequence Number: 6365103
• Product Code: FMQ
• UDI-Device Identifier: 10190676003348
• UDI-Public: 10190676003348
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K963413
• 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): 10/17/2023

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: 4734
• Device Catalogue Number: 4734
• Device Lot Number: 3073T081
• 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: 10/17/2023
• Initial Report FDA Received Date: 11/14/2023
• 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): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown