MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN PROGRIP MESH PRODUCT

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

Patient Problems Pain (1994); Physical Entrapment (2327)

Event Date 09/21/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: bilateral inguinal and umbilical hernia repair.According to the reporter, three hernias were repaired laparoscopically and the mesh did not hold.The mesh migrated and has bunched up.It has been reported that radiology shows mesh from the bottom of the left inguinal canal up to eight inches into the left side of the stomach.There is a solid area of mesh and scar tissue.It has also been reported that this event is resulting in a squeezing of three to five nerves, sperm cord, artery and vein.The patient experiences pain daily for at least 18 moths.The patient has reported issues with sexual issues as a result of the pain.The patient mentions that the mesh moved the velcro on his body and does not hold.Additional information was provided that was speculative in nature by the patient.No other information has been obtained.

Manufacturer Narrative

(b)(4).

• Brand Name: UNKNOWN PROGRIP MESH 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: 4638073
• MDR Text Key: 13167114
• Report Number: 9615742-2015-00020
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 03/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2015
• 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