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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
Patient Problems Adhesion(s) (1695); Erosion (1750); Fistula (1862); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
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 a hernia. It was reported that after the implant, the patient experienced infected mesh, adhesions, enterotomy, serosanguineous fluid, recurrence, migrated mesh, mesh erosion, open wound, fistula, discomfort, mass, serous fluid, and obstructions. Post-operative patient treatment included revision surgery, removal of mesh, debridement of exposed mesh, evacuation of serosanguineous fluid, wound debridement, small bowel resection, repair of enterotomies, hernia repair with new mesh, serous fluid were liberated, and dissection of mesh.
 
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Brand NameUNKNOWN PARIETEX PRODUCT
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 Key11861164
MDR Text Key251931145
Report Number9615742-2021-01352
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,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX PRODUCT
Was Device Available for Evaluation? No
Date Manufacturer Received02/02/2022
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: 05/20/2021 Patient Sequence Number: 1
Treatment
UNKNOWN PROTACK (LOT#UNKNOWN)
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