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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 PCO15X
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Neovascularization (1978); Pain (1994); Hernia (2240); Ascites (2596); Abdominal Distention (2601); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Concomitant product: abstack30x abstack30x abs fixation device30 tacks lot number unknown. (b)(4). 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 an incisional hernia. It was reported that after the implant, the patient experienced recurrence, adhesions, mesh migration, edema, neovascularization, bulging, pain, leukocytosis, left ovarian cyst, and peritoneal fluid in abdominal cavity. Post-operative patient treatment included hernia repair with new mesh, diagnostic laparoscopy, adhesions takedown, and removal of mesh.
 
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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 Key12025343
MDR Text Key258873734
Report Number9615742-2021-01469
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2014
Device Model NumberPCO15X
Device Catalogue NumberPCO15X
Device Lot NumberPGM00090
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
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: 06/18/2021 Patient Sequence Number: 1
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