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

Model Number 2532

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

H3: product is scheduled to be returned but has not been received in by the manufacturing site at the time of this report.Therefore, this report is based solely on the information provided by the customer.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.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.Fda medwatch report (b)(4) / manufacturer reference file (b)(4).H3 other text : product not returned.

Event Description

Customer reporting a complaint on product # 2532.Customer states that a patient was able to loosen their 2532 restraint.The restraint was tightened and the patient was able to loosen it multiple times.Fda medwatch report # (b)(4).

Manufacturer Narrative

Visual findings observed one pair of restraints was received for evaluation.The restraints contain quick release buckles with an older version.No abnormalities have been observed.Evaluation of the returned products found when the application instructions prescribed in the ifu were followed, the restraints did not exhibit slippage issue indicating the product is functional and will perform as intended.However, if the ifu step 1b.Was not followed where the overhand knot with the excess strap was not present to limit unwanted adjustment, the bed connecting strap exhibited slippage due to the male buckle.Possible root cause for this deficiency is that the ifu was not followed while applying this restraint.A review of the complaint database revealed similar events against this device in the past two years leading tidi to redesign the male buckle of the product to mitigate the slipping issue from occurring while the knot is not present.The corrective action is being addressed via capa-2023-0025.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.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.Fda medwatch report 2600320000-2023-8215 / manufacturer reference file (b)(4).

Event Description

Supplemental medwatch being sent for additional information.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: 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: 19081994
• MDR Text Key: 340683829
• Report Number: 2182318-2024-00042
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676004789
• UDI-Public: 10190676004789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

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: 3157T020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Race: Black Or African American