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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Migration or Expulsion of Device (1395); Folded (2630)
Patient Problems Abdominal Pain (1685); Pain (1994); Hernia (2240)
Event Date 08/29/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Prior to (b)(6) 2013, the patient suffered from a supraumbilical hernia. On or around (b)(6) 2013, the patient underwent a laparoscopic incisional hernia repair, by, (b)(6) md, at (b)(6). During the surgery, a parietex composite (pco) mesh was implanted and secured with absorbatack staples ((b)(4)). Following the procedure, the mesh moved, shrunk and folded over causing the patient to suffer recurrence, pain, inflammation and infections. A repeat hernia repair surgery was performed on (b)(6) 2014. It was documented in the operative findings that the mesh was "away from the border of the defect and the mesh had folded inside the abdominal wall defect. " as a result of the defective staples and the movement, shrinking and/or folding-over of the pco mesh, the patient has suffered the following injuries, some or all of which may be permanent in nature: fluid at the hernia site, seroma, erythema, warmth and tenderness at the incision, peri-incisional rash, epigastric pain, fever, chills, swelling of the abdomen, redness and pain at the abdomen, inflammation, hernia recurrence, viral infection/fever/septicemia, difficulty sleeping, stress and anxiety, mental distress and anguish, and pain and suffering.
 
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Brand NameUNKNOWN PARIETEX PRODUCT
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 Key5978009
MDR Text Key55630242
Report Number9615742-2016-00127
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 08/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
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 Received08/30/2016
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 Unkown

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