MAUDE Adverse Event Report: ACELL, INC. MATRISTEM PELVIC FLOOR MATRIX

Model Number	PFM0505
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported dyspareunia or pain during sexual intercourse described by the patient after initial placement of the acell device.The device was not explanted and it is not available for evaluation.The patient has not been treated for dyspareunia.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with acell's operating procedures and federal, state, and local laws and regulations.There were no reports of device failure at the time of initial surgery.
Event or Problem Description
Acell, inc.Became aware that a clinical study participant is experiencing dyspareunia or pain during sexual intercourse after rectocele repair with an acell device on (b)(6) 2017.It is the opinion of the surgeon that the acell device is possibly related to the adverse event.Surgeon thinks scar tissue may have formed during remodeling of graft or it could be due to the rectocele repair.The site of vaginal pain is the anterior wall.The surgeon hypothesizes the change of axis of vagina puts more force on anterior vaginal wall due to lack of flexibility in the posterior wall.Patient has not been treated for the dyspareunia.

• Brand Name: MATRISTEM PELVIC FLOOR MATRIX
• Common Device Name: MATRISTEM PELVIC FLOOR MATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr; columbia MD 21046
• MDR Report Key: 7757135
• Report Number: 3005920706-2018-00010
• Device Sequence Number: 13724310
• Product Code: FTM
• UDI-Device Identifier: 00386190001264
• UDI-Public: (01)00386190001264(17)190430(10)008939
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: No Information
• Device Expiration Date: 04/30/2019
• Device Model Number: PFM0505
• Device Catalogue Number: PFM0505
• Device Lot Number: 008939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 08/07/2018
• 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: Other
• Patient Age: 61 YR