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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 PCO3728X
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Fistula (1862); Unspecified Infection (1930); Necrosis (1971); Sepsis (2067); Seroma (2069); Hernia (2240); Impaired Healing (2378); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Death  
Manufacturer Narrative

(b)(4). Concomitant product: securestrap (product id: strap25, lot no: lez828), securestrap (product id: strap25, lot no: lcm323), pco3728x parietex pcox 37x28cm x1 (prc0045x), sym15 stex rnd 15cm x1 (ppj1040x). 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 ventral hernia. It was reported that after the implant, the patient experienced exposed mesh, wound dehiscence, non-healing wound, chronic abdominal wound, erosion of mesh into bowel, mesh infection, fistula, recurrence, adhesions, abscess, seroma, poorly incorporated mesh, mesh migration, loss of domain, positive for pyoderma gangrenosum, sepsis, death, and necrotic tissue. Post-operative patient treatment included revision surgeries, mesh resutured, wound vac, wound debridement, removal of mesh, split-thickness skin graft, and hernia repair with new mesh, incision/drainage of abscess, evacuation of seroma, takedown of adhesions, small bowel resection, anastomosis, right flank abdominoplasty with advancement flaps of muscle and skin, transported to the icu, remained intubated because of long duration of open abdomen/comorbidities, and excision of necrotic tissue. Information received indicates the patient is now deceased, due to sepsis.

 
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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 Key11859998
MDR Text Key251825514
Report Number9615742-2021-01335
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 05/20/2021
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 HEALTH PROFESSIONAL
Device MODEL NumberPCO3728X
Device Catalogue NumberPCO3728X
Device LOT NumberPRC0045X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/16/2017
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
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