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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SOFRADIM AVAULTA MESH MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SOFRADIM AVAULTA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN AVAULTA MESH
Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Pain (1994); Discomfort (2330); Injury (2348); Foreign Body In Patient (2687)
Event Date 08/14/2007
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6). (b)(4).

 
Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. After the device was implanted, the patient began to experience severe complications related to the implant, including pain, discomfort, urinary problems, dyspareunia.

 
Manufacturer Narrative

Tracking number: (b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameSOFRADIM AVAULTA MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key6198154
MDR Text Key63081119
Report Number9615742-2016-00220
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberUNKNOWN AVAULTA MESH
Device Catalogue NumberUNKPARUGYTEX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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