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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE 1L M BOLT; ICP MICRSOSENSORS - CERELINK
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INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE 1L M BOLT; ICP MICRSOSENSORS - CERELINK Back to Search Results
Catalog Number 826851
Device Problem No Device Output (1435)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
3 of 3 reports.Other mfg report numbers: 3013886523-2024-00039 3013886523-2024-00040.A facility reported a cerelink sensor (b)(6) had very high pressure (300), and then a flat line was seen five hours after placement.The sensor was removed and replaced.The second sensor worked for 11 hours, then suddenly, flat line.It was explanted and monitoring stopped.The sensors were connected to directlink module (id 826828).
 
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
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Brand Name
CERELINK ICP PROBE 1L M BOLT
Type of Device
ICP MICRSOSENSORS - CERELINK
Manufacturer (Section D)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
11 cabot boulevard
mansfield MA
Manufacturer (Section G)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
mansfield MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key18697907
MDR Text Key335270536
Report Number3013886523-2024-00041
Device Sequence Number1
Product Code GWM
Combination Product (y/n)N
PMA/PMN Number
K173192
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Report Date 02/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number826851
Date Manufacturer Received01/25/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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