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

Model Number	2551
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Airway Obstruction (1699)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reporting a complaint on product # 2551.Customer states that the patient was able to bite off & swallow the product label.Resulted in a bronchoscopy procedure to remove the label.Cuff was disposed of and is not available for return.
Additional Manufacturer Narrative
H3 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 noted this event happened while the patient was on his side being attended to, the patient was able to detach the tag located on one of the wrist holders; aspirated the tag which then resulted in a bronchoscopy procedure to remove the tag.Historical complaint data review identified no other similar complaints for this issue for this product family.This appears to be an isolated event.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu warnings state: always monitor patient per facility policy.Improper application or use of any restraint may result in serious injury or death.Be aware that constant monitoring may be required for: aggressive or agitated patients.Never alter or repair this product.Always inspect before each use: check for broken stitches or parts; torn, cut or frayed material; or locks, buckles, or hook-and-loop fasteners that do not hold securely.Do not use soiled or damaged products.Doing so may result in serious injury or death.Dispose of damaged products per facility policy for biohazardous material.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.Manufacturer reference file (b)(4).
Additional Manufacturer Narrative
Additional information added to update tab a patient information, tab d section d4 lot number and tab h section h10 medsun report number from customer.Based on the lot number provided, a review of the device history record (dhr) of the affected lot number did not reveal any 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.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.Report#: (b)(4) and manufacturer reference file: (b)(4).
Event or Problem Description
Supplemental medwatch submitted for additional information related to a previously submitted report.

• Brand Name: 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: 21333059
• Report Number: 2182318-2025-00006
• Device Sequence Number: 8620763
• Product Code: FMQ
• UDI-Device Identifier: 10190676004956
• UDI-Public: 10190676004956
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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: 2551
• Device Catalogue Number: 2551
• Device Lot Number: 4312T071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White