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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; CATHETER, UPPER URINARY TRACT
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DEROYAL INDUSTRIES, INC. DEROYAL; CATHETER, UPPER URINARY TRACT Back to Search Results
Catalog Number 81-080410
Device Problem Insufficient Information (3190)
Patient Problem Blood Loss (2597)
Event Date 01/10/2014
Event Type  Injury  
Event Description
The hospital reported that the foley was inserted on (b)(6) 2014, and then irrigated and changed on (b)(6) 2014.When this occurred there was bleeding from the urethra and they were unable to place another foley.A feeding tube had to be inserted.
 
Manufacturer Narrative
Deroyal: the reported device is not available for evaluation.Investigation into the root cause is in process.
 
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Brand Name
DEROYAL
Type of Device
CATHETER, UPPER URINARY TRACT
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
new tazewell TN
Manufacturer Contact
courtney rinehart
200 debusk lane
powell, TN 37849
8653622122
MDR Report Key3672074
MDR Text Key4343621
Report Number2320762-2014-00005
Device Sequence Number1
Product Code EYC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041416
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/13/2018
Device Catalogue Number81-080410
Device Lot Number34418077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/10/2014
Event Location Hospital
Date Report to Manufacturer01/31/2014
Date Manufacturer Received01/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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