MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL¿; MESH, SURGICAL

Model Number UNKNOWN-PERMACOL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 06/01/2019

Event Type  Death  

Manufacturer Narrative

Title one-year outcomes of infants born with congenital diaphragmatic hernia: a national population cohort study source arch dis child fetal neonatal ed, volume 104, 2019 (f643¿f647) date of publication: 1 june 2019.If information is provided in the future, a supplemental report will be issued.[pe# (b)(4)].

Event Description

According to the literature, (october 2018 to june 2019) this study aimed to evaluate the outcomes up to one year for infants born with congenital diaphragmatic hernia (cdh) that underwent surgical intervention.Post-operative morbidity following patch versus primary closure along with biological versus synthetic patch material were reviewed.Death was reported in 3 patients.Specific biological patch used was not reported in these events, and also the majority of infant deaths in babies born with cdh occur before surgical correction.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL
• 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 Key: 9653498
• MDR Text Key: 177176065
• Report Number: 9615742-2020-00305
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-PERMACOL
• Device Catalogue Number: UNKNOWN-PERMACOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other