MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN PARIETEX PRODUCT; MESH

Model Number UNKNOWN PARIETEX

Device Problems Migration or Expulsion of Device (1395); Folded (2630); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330); Disability (2371)

Event Date 09/21/2012

Event Type  Injury  

Event Description

Procedure: l/r bilateral inguinal and umbilical hernia repair.According to the reporter, the mesh did not hold and it moved and bunched up.The patient reports that the mesh is gripping and rubbing the nerves and sperm cord.The patient has seen many doctors and undergone radiology.The patient reports experiencing shortened erection length and smaller width in addition to experiencing extreme pain for four days following ejaculation.The patient reports experiencing shortened ejaculatory trajectory.He experiences constant searing pain, aching and tightness in his thighs.No further information is expected as no contact information was provided.

Manufacturer Narrative

(b)(4).

• Brand Name: UNKNOWN PARIETEX PRODUCT
• 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: 4826718
• MDR Text Key: 5838192
• Report Number: 9615742-2015-00051
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX
• Device Catalogue Number: UNKNOWN PARIETEX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2015
• 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