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

Model Number SURGIMESH XB

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Abdominal Pain (1685)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

The reporter said that "the xb tintra c-15 was fixated using vicryl suture (cardinal points) and resorbable tacks".The surgimesh xb ifu recommends the use of non-absorbable fixation which the original operating surgeon did not follows.The reoperating doctor was no mention of any defects in the surgimesh xb tintrac15, only that the implant was floating free in the inguinal hernia sac.

Event Description

On (b)(6) 2016 surgeon #1 repaired a small umbilical hernia on the patient laparoscopically using a surgimesh xb tintra c15.The xb tintra c15 was fixated using vicryl suture (cardinal points) and resorbable tacks.On (b)(6) 2017 the patient returned for the repair of an inguinal hernia using an open approach due to groin pain that was being experienced.During the course of the open inguinal repair the operating surgeon, surgeon #2, found the tintral c-15 floating in fluid inside the inguinal hernia sac.The tintrac15 was extracted without incident, the hernia sac closed and the hernia repaired using a bassini technique.The patient remains with the small umbilical hernia awaiting future repair.

• 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
• MDR Report Key: 6800220
• MDR Text Key: 82896529
• Report Number: 3006617478-2017-00005
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 03700296902633
• UDI-Public: 03700296902633
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/16/2017

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: Physician
• Device Expiration Date: 07/15/2019
• Device Model Number: SURGIMESH XB
• Device Catalogue Number: TINTRAC15
• Device Lot Number: F10158A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2014
• 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