MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH XB; MESH, SURGICAL, POLYMERIC

Model Number TINTRA CK-7

Device Problem Contamination (1120)

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 08/28/2015

Event Type  Injury  

Manufacturer Narrative

This manufacturer report #3006617478-2016-00001 has been prepared further to reception of the attached importer report #3005841068-2015-00013.

Event Description

The distributer reported that on (b)(6) 2015 surgeon implanted an xb ck7.During implantation the surgeon had quite a bit if difficulty getting the ck7 in to his satisfaction.The patient's skin did not have any sterile protection film in place so there was quite a bit of contact between the ck7 and the patient's skin during the procedure.On the (b)(6) 2015 the operating room nurse in on the case communicated that the ck 7 was explanted two days after the initial surgery due to an infected seroma near rge implant.

• Brand Name: SURGIMESH XB
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASPIDE MEDICAL; 246 allee lavoisier; la talaudiere, 42350 ; FR 42350
• Manufacturer (Section G): ASPIDE MEDICAL; 246 allee lavoisier; la talaudiere, 42350 ; FR 42350
• Manufacturer Contact: sid ahmed tadjer ; 246 allee lavoisier; la talaudiere, 42350 ; FR 42350 ; 77531659
• MDR Report Key: 5401551
• MDR Text Key: 37226004
• Report Number: 3006617478-2016-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/01/2016
• Device Model Number: TINTRA CK-7
• Device Catalogue Number: TINTRA CK7
• Device Lot Number: F10588A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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): Hospitalization; Required Intervention