MAUDE Adverse Event Report: TIDI PRODUCTS LLC FOAM LIMB HOLDER; RESTRAINT, PROTECTIVE

Model Number	2532
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based solely on the information provided by the customer.Confirmation of customer's complaint and the root cause could not be determined as the product was not returned.A review of the complaint database revealed potential similar events.Of the product complaint where the product was returned, the issue was found to be user error and retraining was offered/performed at the facilities.Another potential cause was determined that the overhand knot was not present as described in the instructions for use step 1b; no following this step will allow the male buckle to slip.This issue has been addressed via internal tidi corrective actions.The device history record (dhr) did not reveal any manufacturing issues that could have contributed to the reported incident.No ncrs were identified.The product passed all verification testing and met manufacturing specifications prior to being released for distribution.The ifu application instructions state to attach the female end of the quick-release buckle (short strap) to the frame that moves with the patient, out of the patient¿s reach (do not attach to side rail or head/footboard).You may also wrap the connecting strap once around the frame to move the buckle out of the patient¿s reach.Secure by feeding the female end through the loop in the strap.Insert the male end of the connecting strap into the female end of the short strap.Listen for a snapping sound, pull firmly on straps to ensure a good connection.To limit unwanted adjustment, tie an overhand knot with the excess strap directly below the quick-release buckle.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 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 warrant.Manufacturer reference file (b)(4).H3 other text : product not returned.
Event or Problem Description
Customer reporting a complaint on product # 2532.Customer states that knots on the restraints are loosening easily.This is happening after they tie the knot so the restraint will not loosen from the bed.Customer states this is part of lot # 3355t050.

• Brand Name: FOAM LIMB HOLDER
• 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: 19334654
• Report Number: 2182318-2024-00062
• Device Sequence Number: 11532362
• Product Code: FMQ
• UDI-Device Identifier: 10190676004789
• UDI-Public: 10190676004789
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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: 2532
• Device Catalogue Number: 2532
• Device Lot Number: 3355T050
• 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: 04/16/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2023
• 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