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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE

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SOFRADIM PRODUCTION SAS PARIETENE Back to Search Results
Model Number PP3030C
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Headache (1880); Unspecified Infection (1930); Inflammation (1932); Memory Loss/Impairment (1958); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Pain (1994); Shock (2072); Skin Discoloration (2074); Urinary Tract Infection (2120); Vomiting (2144); Dizziness (2194); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Irritability (2421); Sleep Dysfunction (2517); Abdominal Distention (2601); Weight Changes (2607); Cramp(s) /Muscle Spasm(s) (4521); Nodule (4551); Unspecified Tissue Injury (4559); Decreased Appetite (4569); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(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 bilateral inguinal hernia with bilateral ilioinguinal nerve block. It was reported that after implant, the patient experienced urinary tract infection, low back/leg/pelvic/groin/testicular pain, abdominal pain, discomfort, cramping, inflammation, infection, swollen and discolored testicles, frequent/inability to urinate, nerve and tissue damage, abnormal growth/masses, groin bulge, nausea, dizziness, insomnia, fatigue, loss of enjoyment of life, defective device, disability, weakness, significant weight loss, loss of appetite, loss of libido, vomiting, psychological/emotional/cognitive problems (insomnia, stress, depression, anxiety, irritability, fear, anger, distrust, uncertainty, despair, memory loss, and cognitive difficulties), shock, headaches, diminished energy, emergence agitation post-anesthesia, and stiffness. Post-operative patient treatment included had to be restrained due to emergence agitation post-anesthesia, requirement of antibiotics and painkillers, and extensive hospital/medical/surgical/pharmacological/therapeutic treatments.
 
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Brand NamePARIETENE
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 Key12698953
MDR Text Key278526769
Report Number9615742-2021-02366
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPP3030C
Device Catalogue NumberPP3030C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
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: 10/26/2021 Patient Sequence Number: 1
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