MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC

Model Number PCO2520X

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

Patient Problems Abdominal Pain (1685); Abscess (1690); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Perforation (2001); Sepsis (2067); Seroma (2069); Swelling (2091); Tachycardia (2095); Ulcer (2274); Injury (2348); Ambulation Difficulties (2544); Blood Loss (2597); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 an incarcerated ventral hernia. It was reported that after implant, the patient experienced perforation, tachycardia, hypotension, sepsis, acute kidney injury, abnormal coagulation, abdominal pain and swelling, difficulty walking, and physical pain and gastrointestinal bleeding. Post-operative patient treatment included revision surgery. On (b)(6) 2014 - a previous admission the patient was admitted and was diagnosed with gastritis, gastroparesis and diabetes and ultimately discharged.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: to date, the incident sample has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted. 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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. Preoperative diagnosis was ­­­­­­­­­a perforated duodenal ulcer. The procedure performed was an exploratory laparotomy for primary repair of duodenal perforation and omental patch.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• 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, CT 80301 ; 3035816943
• MDR Report Key: 7100061
• MDR Text Key: 256517333
• Report Number: 9615742-2017-05940
• Device Sequence Number: 1
• Product Code: FTL
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2019
• Device Model Number: PCO2520X
• Device Catalogue Number: PCO2520X
• Device Lot Number: POI0478X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/08/2017 Patient Sequence Number: 1