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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 Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Nausea (1970); Pain (1994); Scarring (2061); Discomfort (2330); Injury (2348); Abdominal Distention (2601); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: lpg1510al 10x15cm lp antmcl mesh lt (product id: lpg1510al; lot#: psj0993x). (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 chronic pain, nausea, nerve compression, fatty distention, cholelithiasis, abdominal pain, discomfort, scarring, mesh contracted, mesh not attached, and adhesions. Post-operative patient treatment included revision surgery, partial mesh removal, bilateral neurolysis, explore bilateral peripheral nerves, bilateral nerve decompression, bilateral triple neurectomy, re-implant bilateral nerves, and repair bilateral inguinal hernias with 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 Key10603964
MDR Text Key209133352
Report Number9615742-2020-02250
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 09/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLPG1510AR
Device Catalogue NumberLPG1510AR
Device LOT NumberPSK0083X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/25/2018
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: 09/29/2020 Patient Sequence Number: 1
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