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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETENE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PP1510X3C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Emotional Changes (1831); Inflammation (1932); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
Concomitant product: pnp8x3 parietex plug and patch 8 cm cir x3 (lot# sqb0413x). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an inguinal hernia. It was reported that after the implant, the patient experienced pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, loss of enjoyment of life, loss of ability to participate in regular/normal activates, and hernia recurrence,. Post-operative patient treatment included reparative surgery, hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics, medication, therapy, and rehabilitation.
 
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Brand NamePARIETENE
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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12623971
MDR Text Key276145952
Report Number9615742-2021-02277
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model NumberPP1510X3C
Device Catalogue NumberPP1510X3C
Device Lot NumberSPI0451X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/30/2015
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: 10/13/2021 Patient Sequence Number: 1
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