MAUDE Adverse Event Report: TIDI PRODUCTS PELVIC SOFT BELT; RESTRAINT, PROTECTIVE

Model Number 4125C

Device Problem Insufficient Information (3190)

Patient Problem Head Injury (1879)

Event Date 06/15/2022

Event Type  Death  

Manufacturer Narrative

This report is based solely on the information provided by the patient's family member.Product is not available for return, therefore, confirmation of complaint and the root cause could not be determined.A review of the complaint database did not reveal any adverse events for this sku.Therefore, it appears this complaint was an isolated event.The reporter indicated that her mother was under hospital care at (b)(6), where a reported unwitnessed fall occurred while the patient was in her wheelchair on (b)(6) 2022.Several days after the fall, the patient was reported to have bleeding, and was seen by a doctor who confirmed that the patient had a concussion.The patient continued with heavy bleeding and became unconscious, which then resulted in her passing on (b)(6) 2022.The reporter indicated that prior to the incident, she spent every day with her mother who had used the (b)(4).She has no reported issues with the integrity of the product and felt it worked perfect for her mother's needs.The instructions for use (ifu) was reviewed and was found to provide adequate instructions and warnings for safe and effective use of the device.The instructions for use state do not use on a patient who is or becomes highly aggressive, combative, agitated, or suicidal.Warning always monitor patients per facility policy.Improper application or use of any restraint may result in serious injury or death.Test zippers or hook-and-loop fasteners before each use.Discard device if it does not fasten securely.An attempt was made to confirm the event with the hospital, and due to patient privacy, they would not share any information to support the investigation.Without the return of the device, the reported issue could not be confirmed.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.Manufacturer reference file (b)(4).Product not returned.

Event Description

Customer has issued a complaint on product (b)(4).Reporter states her mother was at (b)(6).While there at the hospital, they told her that her mother had an unwitnessed fall (which she didnt believe to be true).She sent a hubspot asking if a person could get out of the (b)(4) by sliding forward.

• Brand Name: PELVIC SOFT BELT
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15974023
• MDR Text Key: 305410123
• Report Number: 2182318-2022-00140
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676003447
• UDI-Public: 10190676003447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2022

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: 4125C
• Device Catalogue Number: 4125C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Death
• Patient Sex: Female