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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 PCO1510X
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fever (1858); Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Seroma (2069); Hernia (2240); Discomfort (2330); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Fibrosis (3167); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant product: unknown absorbatack (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 laparoscopic therapeutic treatment of a incisional epigastric hernia. It was reported that after the implant, the patient experienced distended small bowel, adhesions, hernia recurrence, seroma, infection, hematoma, mesh erosion into viscera, abscess, pain, swelling, drainage, discomfort, fluid collection, blood loss, cloudy fluid, fever, fibrous and adipose tissue, vascular congestions, inflammation, foreign body giant cell reaction, granulation tissue changes, multinucleated giant cells, and open wound. Post-operative patient treatment included small bowel resection, lysis of adhesions, hernia repair with new mesh, drainage of seroma, exploration of surgical wound and abdominal wall, debridement, revision surgery, mesh removal, feeding jejunostomy, fluid aspirated, antibiotics, capsule dissected and excised down to mesh, evacuation of hematoma, wound packed, wound irrigated, and wound vac.
 
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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 Key12326211
MDR Text Key266718416
Report Number9615742-2021-01993
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2013
Device Model NumberPCO1510X
Device Catalogue NumberPCO1510X
Device Lot NumberPLJ00198
Was Device Available for Evaluation? No
Date Manufacturer Received12/15/2021
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: 08/16/2021 Patient Sequence Number: 1
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