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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 LPG1510
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Cyst(s) (1800); Purulent Discharge (1812); Fever (1858); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Seroma (2069); Skin Discoloration (2074); Swelling (2091); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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 recurrence and pain. Post-operative patient treatment included a tap nerve block and revision surgery to remove mesh and implant additional mesh.
 
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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 Key8838614
MDR Text Key152560816
Report Number9615742-2019-02714
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521513136
UDI-Public10884521513136
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142900
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,Followup,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Model NumberLPG1510
Device Catalogue NumberLPG1510
Device Lot NumberPRL1162X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/06/2018
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: 07/29/2019 Patient Sequence Number: 1
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