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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Pulmonary Infarction (2021); Tachycardia (2095); Urinary Retention (2119); Vomiting (2144); Chills (2191); Hernia (2240); Obstruction/Occlusion (2422); Ascites (2596); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant product: pco1510osx parietex pcox skirt 150 cm (lot# pmg00606), pco1510x parietex pcox 15x10 cm x1 (lot# pnj0054x). 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 ventral hernia and right/left inguinal hernias. It was reported that after implant, the patient experienced infection, segmental pulmonary emboli, atelectasis, slowly improving tachycardia, diarrhea, recurrence, oliguria [abnormally small amounts of urine], pain, nausea, vomiting, fever, chills, small bowel obstruction, abdominal pain, serosal traction tear, pulmonary infarcts, inflammation, air-fluid collection, and ileus. Post-operative patient treatment included revision surgery, picc line placed, ng tube, therapeutic anticoagulation for pe, iv hydration, analgesics, hernia repair with new mesh, admission to hospital, lysis of adhesions, serosal traction tear repaired, drain in place, and mesh removal.
 
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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 Key12320847
MDR Text Key266480687
Report Number9615742-2021-01943
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 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2014
Device Model NumberPCO15X
Device Catalogue NumberPCO15X
Device Lot NumberPMI00457
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
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: 08/13/2021 Patient Sequence Number: 1
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