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

Device Problem Human-Device Interface Problem (2949)

Patient Problems Hernia (2240); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

(b)(4).As no lot number was provided, a review of the device history record could not be performed.All process and test criteria are verified as complying with the finished product specifications for all released lots.A review of historical complaint data displayed no increase in trends.

Event Description

According to the reporter, the aim of the study was to evaluate the feasibility and the results of the laparoscopic management of parietal wall defects in patients with a bmi (body mass index) >35.The surgical procedure was standardized: 3 ports, mesh type, fixation with non-absorbable trans-fascial sutures, and tackers.No intraoperative complications or deaths occurred.Although the recurrence rate after incisional and primary ventral hernia treatment is higher in obese patients than in the general population, the complication rate is multifactorial, related to intra-abdominal hyper-pressure in obese patients and to the poorly vascularized subcutaneous fat.Recurrence rate occurred in 3 patients with a bmi of 35.2, 36, and 74, respectively.All recurrences were diagnosed within 12 months after surgery.Additional information has been requested but nothing further has been provided.

• 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: 5010373
• MDR Text Key: 23261773
• Report Number: 9615742-2015-00077
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Report Date: 07/28/2015

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• 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
• Patient Outcome(s): Required Intervention