MAUDE Adverse Event Report: INTERVASCULAR SAS INTRGARD

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/24/2015

Event Type  Injury  

Event Description

The hospital reported that during surgery the infiltration of blood caused a longer for time for patient to stop bleeding.Using a large number of blood products and operating costs were increased.Internal complaint (b)(4).

• Brand Name: INTRGARD
• Manufacturer (Section D): INTERVASCULAR SAS; la ciotat ; FR
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 0000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 5326494
• MDR Text Key: 34418946
• Report Number: 3008355164-2015-00167
• Device Sequence Number: 1
• Product Code: DSY
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other