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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION PCO VENTRAL PATCH 4C MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NamePCO VENTRAL PATCH 4C
Type of DeviceMESH, 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 Key5585011
MDR Text Key42909108
Report Number9615742-2016-00019
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142908
Number of Events Reported1
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 Received04/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2020
Device Model NumberPCO4VP
Device Catalogue NumberPCO4VP
Device Lot NumberPPJ0736X
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 Received05/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2015
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
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