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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 TEM1208GL
Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Edema (1820); Granuloma (1876); Nerve Damage (1979); Pain (1994); Scarring (2061); Hernia (2240); Discomfort (2330); Injury (2348); No Code Available (3191)
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 inguinal hernia. It was reported that after implant, the patient experienced recurrence, nerve damage, dense adheisons, spermatic cord displaced by scarring, scarification of the tissues, shrinkage of mesh, disengagement of mesh, blood supply exceptionally diminished to left testicle and spermatic cord, granulomas, edematous, lack of incorporation, tenderness, pain, and scar encasement. Post-operative patient treatment included revision surgery, hernia repair with new mesh, doppler confirmation of the blood supply of the left testicle and spermatic cord, right genitofemoral neurectomy/neuroplasty, right ilioinguinal neurectomy/neuroplasty, right iliohypogastric neurectomy/neuroplasty, removal of mesh granulomas with multiple foreign bodies, removal of suture, and mesh removal.

 
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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 Key10462925
MDR Text Key204689291
Report Number9615742-2020-01906
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2018
Device MODEL NumberTEM1208GL
Device Catalogue NumberTEM1208GL
Device LOT NumberSNC0678
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/12/2013
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: 08/27/2020 Patient Sequence Number: 1
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