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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL CATHETER KIT

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INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL CATHETER KIT Back to Search Results
Catalog Number 823072
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
1 of 2 reports. Other mfg report number: 3013886523-2021-00219. A physician reported the bactiseal catheter kit and the certas plus valve were removed due to infection. No further information was provided by hospital.
 
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Brand NameCODMAN BACTISEAL CATHETER KIT
Type of DeviceBACTISEAL CATHETER KIT
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key11815805
MDR Text Key256731684
Report Number3013886523-2021-00218
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K102589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2020
Device Catalogue Number823072
Device Lot Number4245171
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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