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

Model Number	PCO3020OSX
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Staphylococcus Aureus (2058); Sepsis (2067); Discharge (2225); Hernia (2240); Injury (2348); Ascites (2596); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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 a hernia repair with mesh.The patient underwent a revision surgery.The patient had infected abdominal mesh, dense adhesions to the recuts musculature as well as omentum and stomach beneath.The mesh had become rolled up on itself.The mesh was excised.
Additional 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 or Problem Description
The patient's attorney alleged a deficiency against the devic.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced infected abdominal mesh, recurrence, antero-mesh fluid collection, hospitalization for sepsis, mesh rolled onto itself, spontaneous drainage and pain from abdominal wound, dense adhesions to the recuts musculature as well as omentum and stomach beneath and foreign body.Post-operative patient treatment included mesh excision, closure of abdominal wound, operative exploration with selective debridement, re-exploration of abdominal wound, removal of foreign body, repair of incisional hernia, evacuation of fluid collection and wound vac.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced infected abdominal mesh, antero-mesh fluid collection, spontaneous drainage and pain from abdominal wound complicated abdominal wound, dense adhesions to the recuts musculature as well as omentum and stomach beneath.The mesh had become rolled up on itself.Post-operative patient treatment included mesh excision, closure of abdominal wound, operative exploration with selective debridement, re-exploration of abdominal wound, debridement, and evacuation of fluid collection and wound vac relevant tests/laboratory data, including dates: (b)(6) 2015: op note- wound cultures positive for (b)(6).

• Brand Name: PARIETEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 6986864
• Report Number: 9615742-2017-05585
• Device Sequence Number: 16172667
• Product Code: FTL
• UDI-Device Identifier: 10884521179776
• UDI-Public: 10884521179776
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K040998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: PCO3020OSX
• Device Catalogue Number: PCO3020OSX
• Device Lot Number: PMF00676
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 05/15/2019; 05/15/2019
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 09/29/2019; 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Weight: 105