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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS BLADE BUR, EAR, NOSE AND THROAT

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MEDTRONIC XOMED INC. XPS BLADE BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 1884005HRE
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/19/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A healthcare professional (hcp) reported that the tip of the blade ruptured in the nasal cavity. The broken pieces of the reported product was remained inside the patient's body.
 
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Brand NameXPS BLADE
Type of DeviceBUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
Manufacturer (Section G)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
Manufacturer Contact
tricha miles
6743 southpoint drive north
jacksonville, FL 32216
7635140379
MDR Report Key10528224
MDR Text Key206764719
Report Number1045254-2020-00405
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1884005HRE
Device Catalogue Number1884005HRE
Device Lot Number0216548455
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 Received08/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/05/2018
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: 09/14/2020 Patient Sequence Number: 1
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