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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETENE MESH PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETENE MESH PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seroma (2069); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)
Event Date 07/06/2021
Event Type  Injury  
Event Description
According to the literature source of study performed between january 2015 and february 2021, which was a retrospective study analyzed outcomes of patients who underwent redo-transversus abdominis release for ventral hernia repair with mesh, there were 65 patients in the study and a composite mesh was used in 5 patients, a monofilament mesh was used in 1 patient and a flat multifilament mesh was used in 1 patient. It was not specified if complications occurred in patients who received the mesh products. It was noted that postoperative complications included: infection, seroma, contaminated mesh and bowel obstruction. Treatment included: antibiotics, wound debridement, percutaneous drainage and reoperations. Two patients underwent reoperation for deep infection with mesh removal and wound dehiscence with mesh exposure. Readmission was required for bowel obstruction and wound complications. Hospital stay was extended with a median of 6 days. Article: k. C. Montelione, 2021, hernia (2021) 25:1581¿1592; https://doi. Org/10. 1007/s10029-021-02457-x; springer-verlag france sas, part of springer nature 2021.
 
Manufacturer Narrative
Title: outcomes of redo-transversus abdominis release for abdominal wall reconstruction source: hernia (2021) 25:1581¿1592 accepted: 6 july 2021. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameUNKNOWN PARIETENE MESH PRODUCT
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 Key14288753
MDR Text Key290811222
Report Number9615742-2022-00429
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 Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETENE MESH PRODUCT
Device Catalogue NumberUNKNOWN PARIETENE MESH PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Yes
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: 05/05/2022 Patient Sequence Number: 1
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