MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETENE PROGRIP RT PPL/PLA 12X8CM; MESH

Model Number PP1208DR

Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 12/03/2007

Event Type  Injury  

Event Description

Procedure: hernia repair according to the reporter, something went wrong during a hernia repair and the patient was re-operated.Another re-operation was performed and a parietene mesh was placed.Later it ruptured and a 4th surgery was performed.During this latest surgery they noticed that the mesh vanished.It was not on the place where it was implanted.The last surgery happened in another hospital.No further patient harm was reported.

Manufacturer Narrative

(b)(4).

• Brand Name: PARIETENE PROGRIP RT PPL/PLA 12X8CM
• Type of Device: MESH
• 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: 4619302
• MDR Text Key: 5659474
• Report Number: 9615742-2015-00014
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: PP1208DR
• Device Catalogue Number: PP1208DR
• Device Lot Number: SHC00403
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 29