MAUDE Adverse Event Report: SOFRADIM PRODUCTION PCO VENTRAL PATCH 4C MESH, SURGICAL, POLYMERIC

Model Number PCO4VP

Device Problem Folded (2630)

Patient Problems Vomiting (2144); Obstruction/Occlusion (2422)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the patient underwent an umbilical hernia repair. Post-operatively, the patient was doing fine. As of (b)(6) 2016, the patient began to complain of not having a bowel movement and vomiting. The patient went to the emergency room on (b)(6) 2016 and was diagnosed with a small bowel obstruction. Exploratory laparotomy was performed on (b)(6) 2016. It was found that the mesh was stuck to itself resulting in the obstruction. A colostomy was performed and the mesh was excised.

Manufacturer Narrative

(b)(4). A review of the device history record of lot #ppj0736x has been performed. This review confirmed that this lot of products was reviewed and released according to qa specifications including those related to the manufacturing and testing of the collagen based film. No product or no picture were provided for evaluation. Without the sample a detailed investigation could not be performed. The reported adhesion is a known potential complication of this type of surgery and is a procedure related complication that is not normally attributed to any product/process deficiencies. The product instructions for use (ifu) which accompanies each device states that the possible complications associated with the use of this device are those typically associated with surgically implantable materials: seroma, hematoma, mesh migration, recurrence, infection, chronic pain, inflammation, visceral adhesion, allergic reactions to the components of the product, fistula formation. It should be noted that the product ifu which accompanies each device also indicates that after insertion of the device, the surgeon should make sure the collagen film is facing visceral structures and ensure that no tissue is trapped between the mesh and the abdominal wall. Based on our investigation and a complaint history review, the manufacture of the device is not suspected. There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend. If additional information is obtained, or the sample is returned, we will re-open this investigation.

Event Description

Additional information received indicated that the white textile adhered to the bowel. Sutures were used to fixate the mesh. All of the sutures were in place at the time of the laparotomy. No colostomy was required.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received that the original report of a colostomy was incorrect and not performed. The umbilical hernia repair was performed on (b)(6) 2016.

• Brand Name: PCO VENTRAL PATCH 4C
• 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: 5585011
• MDR Text Key: 42909108
• Report Number: 9615742-2016-00019
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2020
• Device Model Number: PCO4VP
• Device Catalogue Number: PCO4VP
• Device Lot Number: PPJ0736X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/18/2016 Patient Sequence Number: 1