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

Model Number	SURGIMESH XB
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	06/29/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASPIDE MEDICAL; 246 allee lavoisier; la talaudiere, 42350 ; FR 42350
• MDR Report Key: 6800220
• Report Number: 3006617478-2017-00005
• Device Sequence Number: 1236491
• Product Code: FTL
• UDI-Device Identifier: 03700296902633
• UDI-Public: 03700296902633
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention