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

Model Number	P152030
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	Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Hernia (2240); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product: ethicon mesh prolene 12x12, product id pml, lot # cap332, exp.Date: 2015-01.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 therapeutic treatment of a incisional hernia.It was reported that after the implant, the patient experienced rolled up mesh, abdominal pain, migrated mesh, adhesions, serosal damage to bowels, hernia recurrence, and pain and suffering.Post-operative patient treatment included mesh removal, and revision surgery.

• Brand Name: PERMACOL
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 12112031
• Report Number: 9615742-2021-01645
• Device Sequence Number: 4678865
• Product Code: FTM
• UDI-Device Identifier: 10884523000207
• UDI-Public: 10884523000207
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K120605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• 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): 07/02/2021

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 Expiration Date: 05/30/2012
• Device Model Number: P152030
• Device Catalogue Number: P152030
• Device Lot Number: 09B1101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/02/2021
• 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: Required Intervention