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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL MESH, SURGICAL Back to Search Results
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.
 
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Brand NameMESH TSL - PERMACOL
Type of DeviceMESH, 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 Key11117929
MDR Text Key225109816
Report Number9615742-2021-00023
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
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 Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PERMACOL PRODUCT
Device Catalogue NumberUNKNOWN 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 Received12/09/2020
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
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