MAUDE Adverse Event Report: COOK INC MYOSITE SIMULTANEOUS INJECTION DEVICE; KOG ENDOSCOPE AND/OR ACCESSORIES

Catalog Number	MIN-241625
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.
Event or Problem Description
This adverse event occurred as part of a clinical trial (protocol13-003-05) and there was no allegation of a device malfunction.It was reported that approximately 5 minutes after use of the myosite simultaneous injection device for injection of autologous muscle derived cells (amdc) for stress urinary incontinence the patient developed an allergic reaction of total body flushing and throat constriction.The patient was treated with benadryl, epinephrine, decadron, famotidine, and prednisone and taken to the emergency room for monitoring.The reaction resolved the following day, and she began receiving ongoing benadryl and methylprednisolone.The patient had received a biopsy 70 days prior to this injection, at which point they also began receiving cipro, which continued until the day after the myosite injection.On the day of the procedure she received lidocaine 2%.Urethral dilatation was not required.There were a total of nine injections.

• Brand Name: MYOSITE SIMULTANEOUS INJECTION DEVICE
• Common Device Name: KOG ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8117289
• Report Number: 1820334-2018-03582
• Device Sequence Number: 13978246
• Product Code: KOG
• UDI-Device Identifier: 00827002537408
• UDI-Public: (01)00827002537408(17)170711(10)5125202
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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 Expiration Date: 07/11/2017
• Device Catalogue Number: MIN-241625
• Device Lot Number: 5125202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 80