MAUDE Adverse Event Report: COUSIN BIOTECH CABS'AIR COMPOSITE

Model Number CABSAIRC09

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Adhesion(s) (1695)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

Surgeon confirmed only one patient is involved.Dr.(b)(6) implanted a cabsair composite diameter 9 cm, and he is familiar with the surgical technique and placement recommendations.He did place the 4 recommended sutures to fix the device.Three months after the implantation of the device, the patient presented pain around the implant.Dr (b)(6) decided to reoperate him.During this second surgery, the surgeon found some soft adhesions that were easy to liberate.The implant was explanted and the defect was closed with sutures.Regarding patient's surgical history, dr (b)(6) explained that the patient was very thin (bmi 19) but mainly, he had surgery for a colonic perforation.Dr (b)(6) agreed that an intraperitoneal device was perhaps not the best surgical choice for this patient as it is known that patients who had bowel surgery are more likely to develop adhesions.From this first phone call with dr (b)(6), we can estimate that this case of soft adhesions to the cabsair composite device remains a known complication that is well described in the literature regarding intraperitoneal meshes.The patient was also more suspectable to develop adhesions because of his surgical history.

Event Description

This event has been reported to cousin biotech by a (b)(6) distributor.The patient underwent repair of a hernia with an implant.After a certain period of time, the patient presented bowel adhesions.The patient underwent an additional surgery for the removal of cabsair composite mesh.Today the patient is fine.

• Brand Name: CABS'AIR COMPOSITE
• Type of Device: CABS'AIR COMPOSITE
• Manufacturer (Section D): COUSIN BIOTECH ; 8 rue de l'abbe bonpain; FR
• Manufacturer Contact: franck pelletier ; 8 rue de l'abbe bonpain; wervicq-sud 59117 ; FR 59117 ; 320144119
• MDR Report Key: 5238698
• MDR Text Key: 31926315
• Report Number: 9616062-2015-00002
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K093196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2015

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CABSAIRC09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention