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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 Material Erosion (1214); Material Perforation (2205); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Erosion (1750); Emotional Changes (1831); Fistula (1862); Foreign Body Reaction (1868); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Scarring (2061); Seroma (2069); Ulceration (2116); Hernia (2240); Injury (2348); Deformity/ Disfigurement (2360); Impaired Healing (2378); Post Operative Wound Infection (2446); Blood Loss (2597); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.  the fda was notified of this large complaint receipt.   due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 incisional hernias. It was reported that after implant, the patient experienced abdominal pain, infected mesh, nonhealing abdominal wound, ulceration, abdominal distention, mesh failure, pain, mental anguish, permanent and severe scarring and disfigurement, recurrence, mesh erosion, mesh contraction, infection, fat necrosis, fistula, seroma, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, neuropathic and other acute chronic nerve damage and pain. Post-operative patient treatment included operations to locate and remove mesh, drainage of seroma, placement of wound vac, debridement, abdominoplasty, placement of mesh prosthesis, ultrasound guided peritoneal abscess drained, placement of new mesh, operations to attempt to repair organs, tissue, and nerve damage, and the use of pain control and other medications.
 
Manufacturer Narrative
Surgical intervention, medical intervention, dyspareunia, recurrence.
 
Event Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent the repair of an incisional hernia. Subsequent to the implantation the patient began to have abdominal pain and other symptoms. The patient was diagnosed with an infected mesh and related nonhealing wound and ulceration. Approximately 2 years post op, the patient underwent surgery to repair the exposed and infected mesh. The patient continued to suffer complications and abdominal pain and abdominal distention. The mesh failed, caused serious injury and portions of the mesh had to be surgically removed. The patient has suffered and will continue to suffer both physical injury, pain and mental anguish, permanent and severe scarring and disfigurement. The patient sustained injuries including but not limited to mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, recurrence, dyspareunia, blood loss, neuropathic and other acute chronic nerve damage and pain, requiring the patient to undergo intensive medical treatment, including but not limited to operations to locate and remove mesh, operations to attempt to repair organs, tissue, and nerve damage, and the use of pain control and other medications.
 
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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 avenue
north haven, CT 06473
2034925563
MDR Report Key6967345
MDR Text Key260821553
Report Number9615742-2017-05568
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
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Model NumberTEM1515G
Device Catalogue NumberTEM1515G
Device Lot NumberSMB00591
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/15/2012
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: 10/20/2017 Patient Sequence Number: 1
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