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

Model Number UNKNOWN PERMACOL

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Respiratory Failure (2484); No Code Available (3191)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

Title adverse obstetric history is not a risk factor for poor outcome after ventral rectopexy for obstructive defaecation syndrome.Source colorectal disease.20 (1125-1131), 2018.Date of publication: 01 sept 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature study, after the patients underwent ventral rectopexy (vr) for obstructive defecation syndrome, there were minor and major complications reported.One patient needed transfer to the icu due to respiratory failure.Two further patients required surgical intervention postoperatively: one for an obstructed umbilical hernia and an adhesional small bowel obstruction.Late complications consisted of mesh erosion into the vagina in one patient and pelvic pain in another.

• 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: 8260839
• MDR Text Key: 133528138
• Report Number: 9615742-2019-00163
• 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,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• 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
• Date Manufacturer Received: 12/21/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 57 YR