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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 TEM1515G
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Foreign Body Reaction (1868); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scarring (2061); Seroma (2069); Discharge (2225); Hernia (2240); 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 incisional hernia. It was reported that after the implant, the patient experienced post operative incisional seroma, infected mesh, abscess, pain, lack of incorporation, scar, chronic inflammation (including plasma cells, lymphocytes, histocytes, multinucleated giant cells, eosinophils, rare neutrophils), non-healing wound, fibrosis, foreign body reaction, foreign body granuloma, draining sinus tract, and attenuated fascia. Post-operative patient treatment included wound debridement, incision and drainage, debridement down to fascial tissue, excision of infected hernia mesh, panniculectomy, removal of intraperitoneal and extraperitoneal infected hernia mesh, and repair of incisional hernia with phasix biologic 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 Key9769222
MDR Text Key181354284
Report Number9615742-2020-00488
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model NumberTEM1515G
Device Catalogue NumberTEM1515G
Device Lot NumberSPI1165X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/14/2015
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: 02/28/2020 Patient Sequence Number: 1
Treatment
UNK PROTACK(LOT#: UNKNOWN)
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