MAUDE Adverse Event Report: Cook Inc MYOSITE SIMULTANEOUS INJECTION DEVICE; FHR; Needle, Gastro-Urology

Model Number	G53740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dehydration (1807); Nausea (1970); Diaphoresis (2452)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with stress urinary incontinence received the blinded investigational study drug at a dose of 150 million cells via intramuscular route.Later, the unblind visit was performed where the subject's treatment allocation was confirmed as placebo, post which the patient opted to receive amdc-usr (autologous muscle derived cells) injection using cook myosite simultaneous injection device.The needle functioned normally before the procedure, and no device issues were observed.A field product specialist present during the procedure did not note any abnormalities.Shortly after receiving the amdc-usr injection the patient developed dehydration, chest pain, nausea and diaphoresis (excessive sweating).These events occurred within minutes of the injection procedure resulting in overnight hospitalization.A cardiac evaluation did not indicate a heart-related event.The patient was treated with iv normal saline (0.9%) and zofran (ondansetron).The symptoms resolved, and the subject was discharged from the hospital the following day.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
G4 ¿ pma/510(k) #: exempt.H3 ¿ the device is not being returned for evaluation.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: MYOSITE SIMULTANEOUS INJECTION DEVICE
• Common Device Name: FHR; Needle, Gastro-Urology
• Manufacturer (Section D): Cook Inc; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; +1(812)339-2235
• MDR Report Key: 50857638
• Report Number: 1820334-2026-00996
• Device Sequence Number: 13275222
• Product Code: FHR
• UDI-Device Identifier: 00827002537408
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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
• Operator of Device: Health Professional
• Device Model Number: G53740
• Device Catalogue Number: MIN-241625
• Device Lot Number: 16681529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Hydrochlorothiazide; Lidocaine HCl; Lisinopril; Nitrofurantoin; prophylactic antibiotic
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 209 LB