MAUDE Adverse Event Report: SOFRADIM PRODUCTION LP PRGRP ANTMCL MSH10X15CM LT MESH, SURGICAL, POLYMERIC

Model Number LPG1510AL

Device Problem Hole In Material (1293)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the surgeon implanted the device on an unknown date in (b)(6) 2015. The patient developed a seroma. The surgeon re-operated on the patient and discovered a hole in the mesh. Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4). No sample was provided for investigation. The visual examination of the provided picture shows good integration of the visible piece of mesh except at the -hole- location. The knitting of the textile is visible through the tissue integration. The -hole- is located inside a textile pore. A lack of integration of this pore is highly suspected and could have been induced by seroma. Without the sample a detailed investigation could not be performed. As no lot number was provided, a review of the device history record could not be performed. All process and test criteria are verified as complying with the finished product specifications for all released lots.

Event Description

Additional information received, indicated that the surgeon closed the hole with a single stitch and closed the patient with an open procedure. A 10mm trocar was used to place the mesh. The patient has since successfully recovered.

• Brand Name: LP PRGRP ANTMCL MSH10X15CM LT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5554684
• MDR Text Key: 42071464
• Report Number: 9615742-2016-00016
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: LPG1510AL
• Device Catalogue Number: LPG1510AL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/07/2016 Patient Sequence Number: 1