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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Purulent Discharge (1812); Fistula (1862); Hematoma (1884); Ischemia (1942); Necrosis (1971); Seroma (2069); Tissue Damage (2104); Impaired Healing (2378); Post Operative Wound Infection (2446); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Title: hybrid robotic-assisted transversus abdominis release versus open transversus abdominis release: a comparison of short-term outcomes source: hernia, 2019 (23:37¿42), date of publication: 19 november 2018. Information is provided in the future, a supplemental report will be issued. (b)(4).

 
Event Description

According to the literature source of study, the objective of the study was to compare outcomes between hybrid robotic transversus abdominis release (hrtar) and open transversus abdominis release (otar). A total of 183 patients were included in the study. Post-operatively infection was reported in 29 patients, and of them 21 required procedural intervention. Surgical site infection was defined as an infection of the abdominal wall and was further defined as superficial, deep, or organ space infection and also included: wound cellulitis, non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous or purulent drainage, stitch abscess, seroma, hematoma, infected or exposed mesh, or development of an enterocutaneous fistula. Surgical site occurrence requiring procedural intervention that required opening of the wound, wound debridement, suture excision, percutaneous drainage, or mesh removal.

 
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Brand NameUNKNOWN PARIETEX 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
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8593302
MDR Text Key144525519
Report Number9615742-2019-01656
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 LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 05/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX PRODUCT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2019
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: 05/08/2019 Patient Sequence Number: 1
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