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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015OS
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Muscle Weakness (1967); Pain (1994); Staphylococcus Aureus (2058); Discharge (2225); Hernia (2240); Ulcer (2274); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced chronic pain, adhesions, small bowel obstruction, abscess, and infected mesh. Post-operative patient treatment included debridement and mesh explant ((b)(6) 2009 <(>&<)> (b)(6) 2010).
 
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Brand NameMESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
tracy landers
5920 longbow driv
boulder,co, CT 80301
3035816943
MDR Report Key8312105
MDR Text Key135213183
Report Number9615742-2019-00214
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2013
Device Model NumberPCO2015OS
Device Catalogue NumberPCO2015OS
Device Lot NumberPIC00581
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 02/06/2019 Patient Sequence Number: 1
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