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

Model Number	3060M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer confirmed the product will not be returning for analysis.Therefore, this event is reported based on the information provided by the customer.The customer unit manager reported that the patient was placed in a roll vest and bilateral soft wrist restraints.The patient would vacillate from sleeping to quickly agitated.The patient remained agitated and yelling at team, trying to get out of the bed and was able to pull out of his bswr and rip the roll vest.Md was notified, the patient was re-assessed, and additional meds were ordered prn and hold initiated.Images of product were provided of the failed areas and based on those pictures excessive force is the possible cause for this event due to the patients highly aggressive behavior.The ifu contraindications state do not use on a patient who is or becomes highly aggressive, combative, agitated, or suicidal.The instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.Ifu states always monitor patient per facility policy.Improper application or use of any restraint may result in serious injury or death.Make sure straps cannot slide, loosen, or tighten if the patient pulls on them, or if the bed or chair seat position is adjusted.The patient may suffocate if the straps tighten.If the straps loosen, serious injury or death may occur from: patient escape; or from chest compression or suffocation if the patient becomes suspended in the restraint.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 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.User facility report (b)(4) / manufacturer reference file (b)(4).
Event or Problem Description
Uf/importer report #: (b)(4).Patient became agitated and attempted to get out of bed and punched three times at a nurse, striking the nurse at the third attempt.The patient was placed in bilateral soft wrist restraints and a safety vest restraint.Many hours later, the patient became agitated once again and successfully pulled out the bilateral soft wrist restraints and ripped the fabric of the safety vest trying to get out of bed.There was no staff injury or violence towards the team with this second event, nor did the patient suffer any injuries.Nursing team was concerned about the fabric tears in the safety vest restraint and requested the manufacturer review the safety vest restraint and why the fabric was able to rip apart.Item 3060m lot# 4046t011.

• 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: 20461707
• Report Number: 2182318-2024-00120
• Device Sequence Number: 15395026
• Product Code: FMQ
• UDI-Device Identifier: 10190676002600
• UDI-Public: 10190676002600
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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?: No
• Device Model Number: 3060M
• Device Catalogue Number: 3060M
• Device Lot Number: 4046T011
• 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: 09/16/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 59 KG