MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX COMP STOMY 15CM NO HOLE

Model Number PCOPM15

Device Problems Material Rupture (1546); Defective Device (2588)

Patient Problem Hernia (2240)

Event Date 12/02/2014

Event Type  Injury  

Event Description

Procedure: lap parastomal hernia, sugarbaker technique the customer states that on (b)(6) 2010 a mesh was implanted with a female patient the patient seemed to have a new hernia caused by her stoma.On (b)(6) 2014, during a new operation the surgeon noticed that the mesh was ruptured in the middle (two weeks after the procedure in 2010, the patient was reoperated and an extensive adhesiolyse was done.On (b)(4) 2014, the defect was closed and a symbotex was placed over the current mesh and defect.

Manufacturer Narrative

(b)(4).

• Brand Name: PARIETEX COMP STOMY 15CM NO HOLE
• Type of Device: PARIETEX COMP
• 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 06743 ; 2034925267
• MDR Report Key: 4340488
• MDR Text Key: 21777654
• Report Number: 9615742-2014-00348
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/02/2014

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: Other
• Device Model Number: PCOPM15
• Device Catalogue Number: PCOPM15
• Device Lot Number: PKF00371
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/18/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other