PERMACOL P101828

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 2020-03-26 for PERMACOL P101828 manufactured by Sofradim Production Sas.

Event Text Entries

[186554826] (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186554827] The patient? S attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced recurrence, bacterial infection, open wound, abdominal fluid, abdominal air, abdominal skin thickening, diastasis, mesenteric fat, metabolic acidosis, respiratory failure, ileus, sepsis, bowel perforation, anemia, loss of domain, fibrosis, purulent material drainage, fecal drainage, mesh not incorporated, and adhesions. Post-operative patient treatment included bowel resection, incidental appendectomy, admitted to hospital, iv fluids, iv pressors, antibiotics, tpn, transfusion, hernia repair with new mesh, lysis of adhesions, mesh removal, sutures removed, and skin graft.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615742-2020-00635
MDR Report Key9882632
Report SourceCONSUMER
Date Received2020-03-26
Date of Report2020-03-26
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-26
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 NamePERMACOL
Generic NameMESH, SURGICAL
Product CodeFTM
Date Received2020-03-26
Model NumberP101828
Catalog NumberP101828
Lot Number06B26-1
Device Expiration Date2010-01-30
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. Hospitalization; 2. Required No Informationntervention 2020-03-26

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