MAUDE Adverse Event Report: SOFRADIM PRODUCTION PERMACOL 20X40 1.5MM; MESH, SURGICAL, POLYMERIC

Model Number 5240-150

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); Hernia (2240)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device did not behave as expected.The patient involved had previously an incisional hernia repair procedure.However it appeared to have caused an inflammation and the physician decided to implant the alleged device.After ten days most of the device had dissolved.The rest of the product did not merge with the tissue and it looked as if it was just implanted.About one month after the surgery, the rest of the undissolved product had still not merged with the tissue.The device was cut before implantation to fit the wound by the surgeon.The implant was positioned on enough vascularized tissues.It was also reported that the patient was admitted to the general surgery department with suspicion of an obstruction caused by umbilical hernia.There was unanticipated tissue loss and tissue damage since the wound is still not closed, and is now contaminated.The wound required high spectrum antibiotics treatment.

• Brand Name: PERMACOL 20X40 1.5MM
• 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: 5220311
• MDR Text Key: 31228501
• Report Number: 9615742-2015-00106
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 5240-150
• Device Catalogue Number: 5240-150
• Device Lot Number: APA0633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR