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

Model Number TET1309

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

Patient Problems Abdominal Pain (1685); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: ppm1510x3 parietene macro pp 15x10cmx3 (lot# srk0428x); abstack30 abs fixation device 30 tacks (lot#n8e0459mx).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 laparoscopic therapeutic treatment of bilateral inguinal hernias and a supraumbilical ventral hernia.It was reported that after implant, the patient experienced nausea, vomiting, pain, small bowel obstruction, fibrofatty tissue with mild fibrosis, abdominal pain, coughing, bulge, mesh pulled away, and recurrence.Post-operative patient treatment included revision surgery, hernia repair with new mesh, bilateral component separation, sac excised, and mesh removal.

• Brand Name: PARIETEX
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 11861159
• MDR Text Key: 251929861
• Report Number: 9615742-2021-01349
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180147
• UDI-Public: 10884521180147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982532
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: TET1309
• Device Catalogue Number: TET1309
• Device Lot Number: SRC0771X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Date Device Manufactured: 03/28/2017
• 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
• Treatment: PCO9X PARIETEX PCOX RND 9CM X1 (LOT#PRE0712X)
• Patient Outcome(s): Required Intervention