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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PCOX SKIRT 20X15CM X1 MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION PARIETEX PCOX SKIRT 20X15CM X1 MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015OSX
Device Problem Difficult To Position (1467)
Patient Problems Wound Dehiscence (1154); Pain (1994); Hernia (2240)
Event Date 05/10/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter, the patient was seen on (b)(6) 2012 for a large lower midline hernia lateral to an existing scar (following an appendectomy in 2011). On (b)(6) 2012, the patient was admitted to the hospital with hernia pain. The hernia was manually reduced. A ct scan was performed and confirmed a midline ventral hernia containing small bowel. The patient underwent open incisional hernia repair. The old scar was excised, the adhesion was taken down and the hernia(s) were reduced. Mesh was implanted and secured with secure straps (ethicon). Two days following the surgery, the patient was readmitted with a recurrent hernia. The wound had dehisced and the patient experienced severe pain and nausea. A ct scan was performed and confirmed a recurrent hernia with small bowel trapped in it. A laparotomy was performed for strangulated incisional hernia on (b)(6) 2013. The midline was reopened and there was cellulitis over the incisional hernia. The mesh had "given way inferiorly" and a long loop of "ti" had become incarcerated in the old sac. There was no evidence of peritonitis or overt sepsis, though there was a great deal of turbid fluid in the sac. The mesh was removed. The mesh was not replaced due to the turbid fluid and slightly dusky bowel. The sac was excised and the midline was closed. The wound edges were trimmed. The patient further experienced abdominal distention and shortness of breath postoperatively. He was discharged on (b)(6) 2013. On (b)(6) 2014, the patient returned to "a+e" with a hernia. The surgeon felt the patient was a high risk for surgical repair due to a stroke and cerebral aneurysm that he suffered on unknown dates in 2012. The patient was again admitted on (b)(6) 2015 with increasing abdominal pain. A ct scan showed inflammatory change in the small bowel proximal to richter's hernia. A laparoscopic incisional hernia repair was performed on (b)(6) 2015. During the procedure, an 11mm port was inserted in the right axillary line by open technique, an 11mm port was inserted in the left upper quadrant, a 5mm port was inserted in the epigastrium and a 5mm port was inserted in the right upper quadrant. The dense adhesions were divided. An unknown 20cm x 25cm mesh was inserted and fixed with prolene sutures (ethicon). The mesh was secured with two layers of straps. The patient was discharged on (b)(6) 2015. The allegation against the device is that the design of the mesh skirt and technique required to secure it resulted in the surgeon being unable to properly fasten the mesh to the full perimeter of the defect and allowing the small bowel to become entrapped.
 
Manufacturer Narrative
(b)(4).
 
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Brand NamePARIETEX PCOX SKIRT 20X15CM 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 ave
north haven, CT 06473
2034925267
MDR Report Key5795172
MDR Text Key49562336
Report Number9615742-2016-00089
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2015
Device Model NumberPCO2015OSX
Device Catalogue NumberPCO2015OSX
Device Lot NumberPNB0711
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 Received07/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2013
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: 07/14/2016 Patient Sequence Number: 1
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