MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT PLUS

Model Number GELSOFT PLUS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 10/14/2014

Event Type  Injury  

Event Description

The event was reported to vascutek as follows: in 2004, the patient received a graft-replacement surgery in (b)(6).On (b)(6) 2014, the patient went to "(b)(6)" to have a medical examination, where a blood leak from the implanted graft was found and the patient received another graft-replacement surgery.

Manufacturer Narrative

Device being investigated by (b)(4).Device being evaluated in (b)(4) - not returned to vascutek.

• Brand Name: GELSOFT PLUS
• Type of Device: GELSOFT PLUS
• Manufacturer (Section D): VASCUTEK LTD.; newmains ave.; inchinnan business park; renfrewshire, scotland PA4 9RR; UK PA4 9RR
• Manufacturer Contact: eileen dorsay ; 6200 jackson rd; ann arbour, MI 48103-9300 ; 7346634145
• MDR Report Key: 4255419
• MDR Text Key: 5017174
• Report Number: 9612515-2014-00016
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GELSOFT PLUS
• Device Catalogue Number: 636008P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/14/2014
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2014
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Other