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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNK PARIET PROGRIP
Device Problems Material Erosion (1214); Torn Material (3024)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 09/25/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter: the patient had mesh implant which broke and eroded into his appendix, scrotum, belly and into his bottom. An additional mesh was implanted during the hernia surgery in 2015 without his knowledge. He has had recurrent infections, nerve damage, and organ damage, pig prosthetic tissue implant, bowel damage, bladder damage, pain and an abundance of scar tissue and adhesion due to the mesh. He wanted to have the mesh removed but doctor told him it¿s not possible if removed there would be more damage to his organs. He has depression, mental health issues and taking antidepressants.
 
Manufacturer Narrative
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.
 
Event Description
According to the reporter: the patient had mesh implant which broke and eroded into his appendix, scrotum, belly and into his bottom.
 
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Type of DeviceMESH, SURGICAL, POLYMERIC
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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6750920
MDR Text Key109916163
Report Number9615742-2017-05194
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNK PARIET PROGRIP
Device Catalogue NumberUNK PARIET PROGRIP
Device Lot NumberUNKNOWN
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 Received01/18/2018
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: 07/28/2017 Patient Sequence Number: 1
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