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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TEM1515G
Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Hernia (2240); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 an incisional hernia. It was reported that after implant, the patient experienced abscess, infection / infected mesh, mesh contracture, induration, erythema, fluctuance, purulent material, and recurrence. Post-operative patient treatment included revision surgery, debridement of muscle/ subcutaneous tissue/ skin anterior abdominal wall, removal of mesh, resection of suture material, and hernia repair with complex abdominal wall closure with myofascial flap.
 
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Brand NamePROGRIP
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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key10923114
MDR Text Key218904948
Report Number9615742-2020-02716
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTEM1515G
Device Catalogue NumberTEM1515G
Device Lot NumberSRI1172X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/19/2017
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: 11/30/2020 Patient Sequence Number: 1
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