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

Model Number 2532

Device Problem Off-Label Use (1494)

Patient Problem Concussion (2192)

Event Type  malfunction  

Event Description

Customer reporting a complaint on product # (b)(4).Customer states that the hospital had an event over the weekend with the 2532 being involved.A staff member was injured in the process of the event.

Manufacturer Narrative

H3 a companion product was returned for evaluation but the specific restraint involved in the incident was not returned due to it being involved in a crime.It was reported that a man attacked a group of people in illinois, and one of the people fought back with a hammer and severely injured the patient.He was brought to advocate lutheran general and the man went in for surgery for his injuries sustained, woke up from surgery, and attacked the nurses and security guard.It was reported by the hospital that he was able to get out of the 2532 soft limb holder.The patient was reported as violent when in custody.Through investigation we were not able to determine the type of injuries the nurses or security guard sustained.Of the companion products tested, when the application instructions prescribed in the ifu were followed, 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.The ifu contraindications state do not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.In this case the patient was obviously extremely aggressive, and this was not the proper device to be used.Manufacturer reference file (b)(4).

• 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: 18912687
• MDR Text Key: 337762848
• Report Number: 2182318-2024-00024
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 2532
• Device Catalogue Number: 2532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2023
• 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