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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 PCO12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Fever (1858); Nausea (1970); Pain (1994); Swelling (2091); Hernia (2240); Discomfort (2330); Injury (2348); Abdominal Distention (2601); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: pco12 parietex comp 3d py 12 cir nothr (lot# ple00299). (b)(4). 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 laparoscopic therapeutic treatment of an incisional hernia at the umbilicus. It was reported that after the implant, the patient experienced recurrence, adhesions, acute constipation, diarrhea, discomfort, chronic pain, fever, swelling, nausea, distention, abdominal pain, ibs, gallstones, cholelithiasis, symptomatic/chronic cholecystitis, and suffering. Post-operative patient treatment included revision surgery, lysis of adhesions, cholecystectomy, esophagogastroduodenoscopy (egd) with biopsies gej and gastric antrum/body, and hernia repair with new mesh.
 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key10071308
MDR Text Key191449871
Report Number9615742-2020-01147
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO12
Device Catalogue NumberPCO12
Device Lot NumberPKH00480
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2020
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: 05/19/2020 Patient Sequence Number: 1
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