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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PCOX THR 37X28CM X1 MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION PARIETEX PCOX THR 37X28CM X1 MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO3728X
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Death (1802); Unspecified Infection (1930); Blood Loss (2597)
Event Type  Death  
Event Description
The patient came to the hospital with an obstructed incisional hernia. Patient presented with chest with crepitation, lower segment atelactasis. After a conservative measure in icu, the patient was operated. There was a huge multilocular incisional hernia at kocher incision for open cholecystectomy that was performed approximately 15 years ago. There was complete hemostasis and it was checked for mucosal tear. Only the serosal tear was sutured with vicryl 3. 0. Dissection and adhesiolysis of the small bowel was performed to transverse colon, ascending caecum, omental adhesiolysis. The defect size was 15cm x 20cm. There was no bowel discoloration or constricting ring that needed further management. The mesh was fixated to the defect, so that the edge of the mesh was beyond the edge of the defect with approximately 5cm overlap. There was no evidence of increases of intra-abdominal pressure on capnogram. The mesh was not tightened around the bowel. The patient was in the icu on a ventilator for 24 hours and then was removed from ventilator. The patient was passing gases and stool 48 hours after the operation. On the 3rd day postoperative, due to a bad chest infection the patient was again on a ventilator. The patient was weaned again. Due to bad chest infection, she was on ventilator, suction of secretions. On the 7th day postoperative there was a now offensive, brownish discharge, behind the flank flap mid portion of the wound. It was washed with normal saline and nothing was seen to claim any fecal matter. On the 8th day postoperative by 5pm, there was frank intestinal fluid coming through the wound. An urgent exploratory laparotomy revealed intestinal fluid under both flaps. There was a small hole at (adherent to) the summit of the mesh and there was a small portion ½ -1cm other bowel, omentum that was not affected. Due to adherence of the bowel to the edge of the defect there was no intra-abdominal soiling. There was a resection of that part, ileostomy, mucous fistula. Again the patient was good. There was no other perforation. The suture at the serosal tear was intact. The patient was in the icy again where he was on cardiac support for one week. Then the patient developed irreversible sirs. The patient died on (b)(6) 2016. There were complications due to perforation of the small bowel. There was unanticipated blood loss of over 500ccs due to the complication. There was an extension of 4 hours and a 2nd operation.
 
Manufacturer Narrative
Reference number: (b)(4). No sample and no picture were provided for investigation. Without the sample a detailed investigation could not be performed. A review of the device history record has been performed. This review confirmed that this lot of products was reviewed and released results were within specifications limits for the concerned period. It should be noted that the patient clinical history is complex. The reported infection and fistula are known potential complications of this type of surgery. The product instructions for use (ifu), which accompanies each device, states that: "the possible complications associated with the use of parietex optimized composite mesh are those typically associated with surgically implantable materials: seroma/ hematoma / recurrence / adhesions/ chronic pains/ infection / fistula formation / inflammation/ allergic reactions to the components of the product. " it should be also noted that the product ifu states that: "any foreign material may potentiate or prolong infection in the presence of bacterial contamination, and as such, the use of parietex optimized composite mesh may not be appropriate in infected or contaminated sites. " 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. No immediate action required. The report has been added to our product complaints database which is monitored for similar occurrences.
 
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Brand NamePARIETEX PCOX THR 37X28CM X1
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 avenue
north haven, CT 06473
2034925267
MDR Report Key5964626
MDR Text Key55203973
Report Number9615742-2016-00120
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model NumberPCO3728X
Device Catalogue NumberPCO3728X
Device Lot NumberP0B0586X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2016 Patient Sequence Number: 1
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