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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO8VP
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter during the umbilical hernia repair via laparoscopic procedure, while taking down adhesions and then attempted to insert the device and it would not lay flat. The surgeon took the device out and tried again for that same piece. Then opened another device and tried it again still with the same condition. There was an extended surgical time of 30 minutes or more and to complete the case, the surgeon opened a new one with a different size that worked. There was no patient injury.
 
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Brand NamePARIETEX
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 Key12900193
MDR Text Key281502251
Report Number9615742-2021-02435
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142908
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO8VP
Device Catalogue NumberPCO8VP
Device Lot NumberPVF0097X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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