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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV ONLY CERTAS PLUS SMALL & RA W/SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV ONLY CERTAS PLUS SMALL & RA W/SG Back to Search Results
Catalog Number 828814PL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
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
A physician reported the certas plus valve malfunctioned and revision/medical intervention was required. No additional information has been provided.
 
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Brand NameCRTS SM IL SG VLV ONLY
Type of DeviceCERTAS PLUS SMALL & RA W/SG
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 08540
6099362319
MDR Report Key11073568
MDR Text Key223732243
Report Number3013886523-2020-00266
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828814PL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2021
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 Unkown

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