MAUDE Adverse Event Report: TEI BIOSCIENCES INC. PRIMATRIX AG; WOUND COVER

Model Number 607-105-225

Device Problems Improper or Incorrect Procedure or Method (2017); Microbial Contamination of Device (2303)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 04/01/2015

Event Type  Other  

Event Description

The pt had the device implanted during surgery on (b)(6) 2014 underneath a flap.On (b)(6) 2015 the pt returned because the wound had dehisced slightly.The doctor noticed a foul odor and that the wound began to tunnel, the wound was probed and a piece of tissue was removed.The removed material was evaluated.It was determined that the wound was infected and that the material removed appeared to be gauze.It is probable that the pt's condition (contamination/infection) and/or the residual gauze contributed/caused the device to fail.This occurred four months following surgery.The device instructions for use caution against use of the device in an infected surgical location.

Manufacturer Narrative

The device history record for this device was reviewed and everything was in order.The material that was returned for eval and thought to be the device turned out to be gauze.

• Brand Name: PRIMATRIX AG
• Type of Device: WOUND COVER
• Manufacturer (Section D): TEI BIOSCIENCES INC.; boston MA
• Manufacturer Contact: robert buehler ; 7 elkins st.; boston, MA 02127 ; 6172681616
• MDR Report Key: 4867738
• MDR Text Key: 6060954
• Report Number: 3004170064-2015-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 0100261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 607-105-225
• Device Lot Number: 1311013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• 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): Required Intervention
• Patient Weight: 95