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

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

Patient Problems Abdominal Pain (1685); Pain (1994); Hernia (2240)

Event Date 08/29/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Prior to (b)(6) 2013, the patient suffered from a supraumbilical hernia.On or around (b)(6) 2013, the patient underwent a laparoscopic incisional hernia repair, by, (b)(6) md, at (b)(6).During the surgery, a parietex composite (pco) mesh was implanted and secured with absorbatack staples ((b)(4)).Following the procedure, the mesh moved, shrunk and folded over causing the patient to suffer recurrence, pain, inflammation and infections.A repeat hernia repair surgery was performed on (b)(6) 2014.It was documented in the operative findings that the mesh was "away from the border of the defect and the mesh had folded inside the abdominal wall defect." as a result of the defective staples and the movement, shrinking and/or folding-over of the pco mesh, the patient has suffered the following injuries, some or all of which may be permanent in nature: fluid at the hernia site, seroma, erythema, warmth and tenderness at the incision, peri-incisional rash, epigastric pain, fever, chills, swelling of the abdomen, redness and pain at the abdomen, inflammation, hernia recurrence, viral infection/fever/septicemia, difficulty sleeping, stress and anxiety, mental distress and anguish, and pain and suffering.

• Brand Name: UNKNOWN PARIETEX PRODUCT
• 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: 5978009
• MDR Text Key: 55630242
• Report Number: 9615742-2016-00127
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• 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: Unknown
• Patient Sequence Number: 1