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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO15
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Concomitant product: pco12 parietex comp 3d py 12 cir nothr, (lot # pjf00699). 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 laparoscopic therapeutic treatment of a ventral hernia and an umbilical hernia. It was reported that after implant, the patient experienced recurrence. Post-operative patient treatment included revision surgery.
 
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Brand NameMESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
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 Key11607815
MDR Text Key243555494
Report Number9615742-2021-00763
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040998
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,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2013
Device Model NumberPCO15
Device Catalogue NumberPCO15
Device Lot NumberPII00591
Was Device Available for Evaluation? No
Date Manufacturer Received01/12/2022
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: 04/02/2021 Patient Sequence Number: 1
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