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

Model Number UNKNOWN PERMACOL PRODUCT

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

Patient Problem Perforation (2001)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

Title: cartilage sparing septal perforation repair using rotation flaps and a collagen interposition graft: a case series source: annals of otology, rhinology & laryngology 1¿7. If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed between 2011 and 2017, a study analyzed 54 patients who underwent cartilage sparing septal perforation repair using rotation flaps and a collagen interposition graft using permacol. The primary outcome measure was an intact nasal septum one year post-operatively. The perforation size ranged from pin-hole to greater than 4 cm. Post-operative complications included 2 infections which were treated with oral antibiotics and failure of repair. Post-operative complications included 2 infections which were treated with oral antibiotics and failure of repair. Intact septum occurred in: 70% with perforations less than 1 cm, 77% with perforations 1-2 cm, 82% with perforations 2-3 cm, 0% with perforations above 3 cm. The author stated, ¿it was unclear why the failure rate for very small perforations was relatively high¿. Three patients with large perforations required a revision surgery though the author states other techniques may be more suitable for perforations greater than 3 cm.

• 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: 11117929
• MDR Text Key: 225109816
• Report Number: 9615742-2021-00023
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN PERMACOL PRODUCT
• Device Catalogue Number: UNKNOWN PERMACOL PRODUCT
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/05/2021 Patient Sequence Number: 1