MAUDE Adverse Event Report: TEI BIOSCIENCES INC. SURGIMEND; SURGICAL MESH

Model Number 606-001-004

Device Problems Material Disintegration (1177); Material Rupture (1546); Human-Device Interface Problem (2949)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Exploratory surgery was scheduled for (b)(6) 2014 following a prior abdominal surgery in (b)(6) 2014.At the time of the exploratory surgery, the surgeon noted that the pt's abdomen was "nasty" and the colon was infected.The surgeon performed an inguinal repair where the surgimend device was implanted on (b)(6) 2014.On (b)(6) 2014, it was noted that the device had partially disintegrated.The margins were still intact, but the entire body of the device had disrupted.At that point the surgeon elected to implant a second device.There have been no issues with the second device.The surgeon indicated the pt had an infection in a contaminated surgical field.It is not known if the first device has been explanted.It is not known what the pt's current condition is.It is probable that the pt's condition (contamination/infection) contributed/caused the device to fail.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.

• Brand Name: SURGIMEND
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): TEI BIOSCIENCES INC.; boston MA
• Manufacturer Contact: robert buehler ; 7 elkins st.; boston, MA 02127 ; 6172681616
• MDR Report Key: 4359799
• MDR Text Key: 17588383
• Report Number: 3004170064-2014-00283
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 071807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: 606-001-004
• Device Lot Number: 1304003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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; Life Threatening; Other