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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8830415001
Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Skin Irritation (2076); Unintended Radiation Exposure (4565)
Event Date 10/10/2017
Event Type  Injury  
Manufacturer Narrative
Additional information: rfnr (changed to customer discarded), fdp codes and rfr was updated and changed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, after catheter implantation, the patient incurred a cutaneous lesion due to incompatible malleability of the device. It was said that it was necessary to perform an x-ray to check positioning because access was being lost due to its malleability.
 
Manufacturer Narrative
To date, the incident sample has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, on (b)(6) 2017, after a procedure with the catheter, the patient incurred a cutaneous lesion due to incompatible malleability of the product. The patient is alive with noted injury.
 
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Brand NameMAHURKAR
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
jacqueline st. pierre
15 hampshire street
mansfield, MA 02048
5084524938
MDR Report Key7021850
MDR Text Key248710756
Report Number3009211636-2017-05344
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/29/2021
Device Model Number8830415001
Device Catalogue Number8830415001
Device Lot Number1621000154
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/10/2017 Patient Sequence Number: 1
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