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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREAGH MEDICAL LTD DYNAMIS HP DYNAMIS HP PTA BALLOON DILATATION CATHETER

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CREAGH MEDICAL LTD DYNAMIS HP DYNAMIS HP PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number UHP7584
Device Problem Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2019
Event Type  malfunction  
Manufacturer Narrative
The customer has reported noticing a hole in the balloon. No further information has been provided at the time of the initial 30-day report.
 
Event Description
The customer has reported noticing a hole in the balloon.
 
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Brand NameDYNAMIS HP
Type of DeviceDYNAMIS HP PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
CREAGH MEDICAL LTD
ida business park
ballinasloe, H53 K 8P4
EI H53 K8P4
Manufacturer (Section G)
CREAGH MEDICAL LTD
ida business park
ballinasloe, H53 K 8P4
EI H53 K8P4
Manufacturer Contact
shane costello
ida business park
ballinasloe, H53 K-8P4
EI   H53 K8P4
MDR Report Key8896531
MDR Text Key191919445
Report Number3005994106-2019-00009
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102645
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 08/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUHP7584
Device Lot Number21801323
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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