MESH SOFRADIM - PARIETEX? COMPOSITE MESH PCO2520

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for MESH SOFRADIM - PARIETEX? COMPOSITE MESH PCO2520 manufactured by Sofradim Production Sas.

Event Text Entries

[186293945] (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186293946] The patient? S attorney alleged a deficiency against the device. The product was used for laparoscopic therapeutic treatment of a ventral hernia. The patient experienced small bowel obstruction, fistula, adhesions, ileocolic anastomosis stricture, crohn's disease, fever, tachycardia, intussusception, piece of mesh found inside lumen of sigmoid colon, and mesh migration. Post-operative patient treatment included revision surgery, lysis of adhesions, removal of prior mesh, repair of sigmoid colon defect, resection of ileal fistula, strictureplasty, enterotomy, previously placed mesh was debrided as much as possible, wound kept open and packed, and ileal cecal anastomosis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615742-2020-00762
MDR Report Key9900978
Report SourceCONSUMER
Date Received2020-03-30
Date of Report2020-03-30
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1SOFRADIM PRODUCTION SAS
Manufacturer Street116 AVENUE DU FORMANS
Manufacturer CityTREVOUX 01600
Manufacturer CountryFR
Manufacturer Postal Code01600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMESH SOFRADIM - PARIETEX? COMPOSITE MESH
Generic NameMESH, SURGICAL, POLYMERIC
Product CodeFTL
Date Received2020-03-30
Model NumberPCO2520
Catalog NumberPCO2520
Lot NumberPJG00307
Device Expiration Date2014-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSOFRADIM PRODUCTION SAS
Manufacturer Address116 AVENUE DU FORMANS TREVOUX 01600 FR 01600


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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