MESH SOFRADIM - PARIETEX? COMPOSITE MESH PCO3728

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 PCO3728 manufactured by Sofradim Production Sas.

Event Text Entries

[188065280] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188065281] The patient? S attorney alleged a deficiency against the device. The product was used for laparoscopic therapeutic treatment of multiple incisional hernias. It was reported that after the implant, the patient experienced recurrence, pain, adhesions, abdominal pain, infection, mesh had areas of laxity and hardness, necrosis, and mesh indurated. Post-operative patient treatment included revision surgery, debridement of wound, excised mesh, lysis of adhesions, small bowel resection with anastomosis, removal of some of the infected area of synthetic mesh in lower abdominal area, removal of excess skin and subcutaneous tissue off the abdominal wall, repair a dome of the bladder cystotomy, wound vac, wound dressings, debridement of necrotic abdominal wall skin, subcutaneous tissue and fascia with reclosure of the complicated abdominal wall wound defect, prolene sutures removed, and recurrent incisional hernia repaired with new bard mesh.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615742-2020-00754
MDR Report Key9900713
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 NumberPCO3728
Catalog NumberPCO3728
Lot NumberPIF00397
Device Expiration Date2013-05-30
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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