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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 LPG1510AR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Nerve Damage (1979); Pain (1994); Irritability (2421); Cramp(s) /Muscle Spasm(s) (4521); 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 laparoscopic therapeutic treatment of an inguinal hernia.It was reported that after the implant, the patient experienced nerve damage, pain, groin pull, spasm, nervousness, tension, irritability, inflammation, and femoral nerve injury.
 
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Brand Name
PROGRIP
Type of Device
MESH, 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 Key11794550
MDR Text Key249658518
Report Number9615742-2021-01017
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521513167
UDI-Public10884521513167
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120897
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 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Model NumberLPG1510AR
Device Catalogue NumberLPG1510AR
Device Lot NumberPQG0332X
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/21/2021
Initial Date FDA Received05/07/2021
Date Device Manufactured07/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight65
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