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

Model Number P152040

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Dyspnea (1816); Edema (1820); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: tet3030 parietex std 3d py 30x30cm x1, (lot # sll00060).(b)(4).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 an incisional hernia and stomal hernias.It was reported that after the implant, the patient experienced separation of mesh, adhesions, painful bulge, mesh erosion into viscera, obstruction, pneumatosis intestinalis, edema, inflammation, fibrosis, hemorrhages, fibroadipose tissue, foreign body reaction, dyspnea, abdominal pain, and recurrence.Post-operative patient treatment included revision surgery, dissection of mesh, take down of adhesions, small bowel resection with primary anastomosis, primary repair of two enterotomies, wound irrigation, and hernia repair with new mesh.

• Brand Name: PERMACOL
• Type of Device: MESH, SURGICAL
• 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 ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10053671
• MDR Text Key: 190889328
• Report Number: 9615742-2020-01072
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120605
• 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
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2014
• Device Model Number: P152040
• Device Catalogue Number: P152040
• Device Lot Number: 11B0601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• 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): Required Intervention
• Patient Weight: 100