MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS ACCUMESH; MESH, SURGICAL, DEPLOYER

Model Number	AMPPCO15X
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Hernia (2240); Ascites (2596); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: pco15x parietex pcox rnd 15cm x1 (lot# unknown).(b)(4).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.The product was used for laparoscopic therapeutic treatment of an incisional hernia.It was reported that after the implant, the patient experienced erosion, abdominal mass, migration, inflammation, space filled with fluid, abscess, infection, recurrence, serosanguineous fluid, swelling, serous fluid, and wound drainage.Post-operative patient treatment included removal of mesh/mass, hernia repair with new mesh, evacuation of serosanguineous fluid, admission to hospital, and mesh dissection.

• Brand Name: ACCUMESH
• Common Device Name: MESH, SURGICAL, DEPLOYER
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 11844813
• Report Number: 9615742-2021-01259
• Device Sequence Number: 16871600
• Product Code: ORQ
• UDI-Device Identifier: 10884521174696
• UDI-Public: 10884521174696
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K130782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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 Model Number: AMPPCO15X
• Device Catalogue Number: AMPPCO15X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/18/2021
• 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; Required Intervention
• Patient Weight: 81