MESH TSL - PERMACOL? UNKNOWN-PERMACOL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-24 for MESH TSL - PERMACOL? UNKNOWN-PERMACOL manufactured by Sofradim Production Sas.

Event Text Entries

[187613162] (b)(4). Title perioperative complications of complex abdominal wall reconstruction with biologic mesh: a pooled retrospective cohort analysis of 220 patients from two academic centers source international journal of surgery, volume 74, 2020 (94? 99) date of publication: 28 december 2019. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[187613203] According to the literature source of study performed aimed to identify perioperative predictors of outcomes after complex abdominal wall reconstruction (cawr) with biologic mesh (bm). In this retrospective study, perioperative complications were analyzed in all patients who underwent open cawr with bm over six years in two academic centers. There were 220 patients included in the study and 8 were implanted with the company's complication. Post-operatively wound infections were reported in 28 patients and 26 of them required a wound vacuum-assisted closure. 13 patient require mechanical ventilation and 47 of the patient require reoperation. The reasons for patient reoperation were not reported. Which mesh was used in the reported adverse events was not reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615742-2020-00624
MDR Report Key9872351
Report SourceHEALTH PROFESSIONAL,LITERATUR
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-01-08
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-24
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 TSL - PERMACOL?
Generic NameMESH, SURGICAL
Product CodeFTM
Date Received2020-03-24
Model NumberUNKNOWN-PERMACOL
Catalog NumberUNKNOWN-PERMACOL
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. Other 2020-03-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.