MAUDE Adverse Event Report: SOFRADIM PRODUCTION PCO VENTRAL PATCH 8C; MESH, SURGICAL, POLYMERIC

Model Number PCO8VP

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: umbilical hernia repair.According to the reporter: as per the suggested technique.The dr.Is not a regular user of this mesh (it is only the third time he has performed this procedure with this product).The hernia defect measured around 3cm, he selected this product, as the best size for this particular defect.After introducing the mesh through the defect, into the abdominal cavity, the mesh folded onto itself (away from the viscera, toward the inside of the abdomen).After numerous attempts to reposition the mesh flat against the abdominal wall/peritoneum, it eventually had to be removed.The handles did not seem to lift the other half of the mesh, but rather kept it folding double upon itself (when pulling it up).To complete the case a new piece of mesh was used.There was a slight delay in surgery (around 10 min in total), but there was no significant tissue damage or blood loss.No particulate matter came loose from the mesh/ or fell into patient abdomen.

• Brand Name: PCO VENTRAL PATCH 8C
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473
• MDR Report Key: 6152492
• MDR Text Key: 61734010
• Report Number: 9615742-2016-00199
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K120506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCO8VP
• Device Catalogue Number: PCO8VP
• Device Lot Number: PQE0277X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1