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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 Unspecified Infection (1930); Pain (1994); Hernia (2240); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: lpg1510al 10x15cm lp, antmcl mesh lt, lot number: pta1923x. (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 an inguinal hernia. It was reported that after implant, the patient experienced infection, chronic pain, hernia recurrence, cord lipoma, and swollen abdomen. Post-operative patient treatment included revision surgery, resection of cord lipoma, and hernia repair with new 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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12218004
MDR Text Key263154454
Report Number9615742-2021-01807
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2020
Device MODEL NumberLPG1510AR
Device Catalogue NumberLPG1510AR
Device LOT NumberPRF0714X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/22/2017
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: 07/23/2021 Patient Sequence Number: 1
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