MAUDE Adverse Event Report: SOFRADIM PRODUCTION PCO VENTRAL PATCH 6C GENERAL & PLASTIC SURGERY

Model Number PCO6VP

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

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

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). (b)(6). User facility listed in initial reporter. (b)(4).

Event Description

According to the reporter, during an umbilical hernia repair the mesh was difficult to adhere. The hernia defect measured around 3 cm. The mesh folded fascial side against fascial side (textile side), the violet expanders were broken, a small infra-umbilical incision was made to place mesh in the intra-peritoneal position (in direct contact with bowel), and the mesh was not cut prior to implantation. Sutures were used to fixate the mesh. Before implantation: the mesh looked normal, the reporter could not provide any information on the pla ring. No trocar was used as this was open surgery. After numerous attempts to position the mesh flat against the abdominal wall/peritoneum it eventually had to be removed. It was reported that the integrity of the pla-ring was compromised due to, what seemed to be weakened areas on it. The mesh also now had damage to the anti-adhesion barrier due to the attempt to flatten it out. A second unit pco6vp (with a different lot number) was used to complete the procedure. There was a 3 minute delay in theatre time. Patient status, stable, recovered.

Manufacturer Narrative

(b)(4). A review of the device history record has been performed. This review confirmed that this lot of products was released according to qa specifications. Especially, the manufacturing and qc records related to the molding of the ring and collagen film casting were found within qa specifications. Conclusion of the visual examination: the returned sample does not match with the incident description, as it was not clinically used and so has not been inserted inside the patient body. The returned sample does not seem to be the involved sample in this complaint (i. E. Demo sample suspected). Handling rough is highly suspected to explain the violet expanders damages. The report has been added to our product complaints database which is monitored for similar occurrences. Based on the available information, our investigation and a complaint history review, the manufacture of the device is not suspected. There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend. No immediate action required. The returned sample does not seem to be the involved sample of this complaint (i. E. Demo sample suspected). The root cause could not be reliably determined.

Manufacturer Narrative

(b)(4).

Event Description

The wound was closed with 2-0 vicryl suture and a monocryl 3-0 for the subcutaneous skin closure followed by steristrips and an obsite.

• Brand Name: PCO VENTRAL PATCH 6C
• Type of Device: GENERAL & PLASTIC SURGERY
• 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
• MDR Report Key: 5959685
• MDR Text Key: 55023942
• Report Number: 9615742-2016-00121
• 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,health professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: PPC1100X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial