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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 TEM3015G
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Purulent Discharge (1812); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Staphylococcus Aureus (2058); Injury (2348); Impaired Healing (2378); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(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 therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced infection, open wound, abscess, purulent drainage, inflammation, granulation tissue, necrosis, foreign body reaction, fibrosis, (b)(6), mesh peeled off, desiccation of fascial edges, and abdominal pain. Post-operative patient treatment included revision surgery, removal of mesh due to infection, wound exploration, incision and drainage of abscess, placement of wound vac, abdominal wound washout, drain placed, antibiotics, and wound vac change.

 
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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 Key10705357
MDR Text Key212106399
Report Number9615742-2020-02360
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 10/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTEM3015G
Device Catalogue NumberTEM3015G
Device LOT NumberSRE0679X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/24/2017
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: 10/20/2020 Patient Sequence Number: 1
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