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

Model Number PSM0412

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

Patient Problems Obstruction/Occlusion (2422); Patient Problem/Medical Problem (2688)

Event Date 09/19/2016

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. Tests of a retain sample from the same lot met lot release specifications. This mdr has been filed out of an abundance of caution.

Event Description

Patient developed a small bowel obstruction three weeks after a colon anastomosis procedure in which the surgeon employed an acell device. The obstruction required surgical intervention.

• Brand Name: MATRISTEM SURGICAL 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: 6158744
• MDR Text Key: 61896933
• Report Number: 3005920706-2016-00007
• 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

• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/30/2018
• Device Model Number: PSM0412
• Device Lot Number: SM6209-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/09/2016 Patient Sequence Number: 1