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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE; BUR, EAR, NOSE AND THROAT
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MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE; BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 1884002
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation.A product analysis has not been performed.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reported that the xps blade snapped preoperative.The customer refused to return the device for analysis.
 
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Brand Name
XPS® BLADE
Type of Device
BUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
angie demo
6743 southpoint drive north
jacksonville, FL 32216
9043328355
MDR Report Key7142919
MDR Text Key95749892
Report Number3004209178-2017-26580
Device Sequence Number1
Product Code EQJ
UDI-Device Identifier20681490047443
UDI-Public20681490047443
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1884002
Device Catalogue Number1884002
Device Lot NumberHG1R6BQ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/08/2017
Initial Date FDA Received12/22/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/21/2017
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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