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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 TECT1510AR
Device Problems Migration or Expulsion of Device (1395); Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Seroma (2069); Hernia (2240); Injury (2348); Ascites (2596); Abdominal Distention (2601); No Code Available (3191)
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 implant, the patient experienced hematoma, recurrent ventral incisional hernia repaired with new symbotex mesh, drainage of ascites, hematoma, left groin seroma, recurrence of left inguinal hernia repaired with progrip mesh, drainage of peritoneal fluid, inguinal bulging due to parietex mesh protrusion through the peritoneal cavity. Treatment provided for these conditions include removal and revision surgery.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.  the fda was notified of this large complaint receipt.  due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. Concomitant medical products: sym1510 stex 15x10 cm x1 (lot# unknown), abstack30 abs fixation device 30 tacks (lot# unknown). 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 incisional hernia and bilateral inguinal hernia. It was reported that after implant, the patient experienced recurrence, peritoneal fluid, protrusion of corner of mesh, hematoma, seroma, and bulging. Post-operative patient treatment included revision surgery, repair of hernia with mesh, excision of mesh, drainage of peritoneal fluid, pushed old piece of mesh in and sewed it to inguinal ligament and cooper ligament.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. (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 therapeutic treatment of incisional hernia and bilateral inguinal hernia. It was reported that after implant, the patient experienced recurrence, peritoneal fluid, protrusion of corner of mesh, hematoma, seroma, mesh migration, ascites, large loculated sac, and bulging. Post-operative patient treatment included revision surgery, repair of hernia with mesh, excision of mesh, drainage of peritoneal fluid, pico wound vac, pushed old piece of mesh in and sewed it to inguinal ligament and cooper ligament.
 
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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
MDR Report Key8001959
MDR Text Key124898770
Report Number9615742-2018-02440
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K982532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTECT1510AR
Device Catalogue NumberTECT1510AR
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/24/2018 Patient Sequence Number: 1
Treatment
UNKNOWN PARIETEX PRODUCT (LOT# UNKNOWN)
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