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

Model Number PCO12X

Device Problems Degraded (1153); Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Inflammation (1932); Ischemia (1942); Nausea (1970); Pain (1994); Hernia (2240); Discomfort (2330); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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 a incisional hernia.It was reported that after the implant, the patient experienced adhesions, benign fibrofatty tissue, inflammation, bowel obstruction, ischemic bowel, pain, tenderness, nausea, mesh thickened, mesh contracted, mesh folded, nonincorporated mesh, and hernia recurrence.Post-operative patient treatment included mesh removal surgery, partial omentectomy, lysis of adhesions, repair of hernia with mesh, open component separation technique, bilateral component separation with creation trunk myofascial flaps, laparotomy enterolysis, and exploratory laparotomy.

• 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: 11986208
• MDR Text Key: 255772852
• Report Number: 9615742-2021-01451
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179745
• UDI-Public: 10884521179745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: PCO12X
• Device Catalogue Number: PCO12X
• Device Lot Number: PLF00519
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• 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 Age: 47 YR