MAUDE Adverse Event Report: ACELL, INC MATRISTEM PELVIC FLOOR MATRIX; MESH, SURGICAL

Model Number PFM0912

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 11/26/2016

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was conducted on discovery.A review of the manufacturing records for the lot identified no substantial deviation and demonstrated that the product was manufactured and distributed in compliance with fda, state, and local laws, as well as all manufacturer operating procedures.There was no report of device failure from the treating physician at the time of surgery.A sister graft from the same lot was tested for sterility and results of no growth substantiated that the lot was supplied sterile.This mdr has been filed out of an abundance of caution.

Event Description

Patient developed an infection approximately 8 days after a posterior vaginal wall repair in which the surgeon employed an acell device.Patient was admitted into the hospital and administered intravenous antibiotics.Patient was discharged with oral antibiotics on (b)(6) 2016 and has not since returned.

• Brand Name: MATRISTEM PELVIC FLOOR MATRIX
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ACELL, INC; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer (Section G): ACELL, INC; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer Contact: barry brainard ; 6640 eli whitney dr.; columbia, MD 21046 ; 8034870493
• MDR Report Key: 6214402
• MDR Text Key: 63606646
• Report Number: 3005920706-2016-00008
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: PFM0912
• Device Lot Number: SM7336-66
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization