MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP; MESH, SURGICAL, POLYMERIC

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

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.

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.

• Brand Name: PROGRIP
• Type of Device: MESH, 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 Key: 6967345
• MDR Text Key: 89913003
• Report Number: 9615742-2017-05568
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• 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 Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: TEM1515G
• Device Catalogue Number: TEM1515G
• Device Lot Number: SMB00591
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 103