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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUKAL CORPORATION REGARD; SPONGE LAP X-RAY DET

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DUKAL CORPORATION REGARD; SPONGE LAP X-RAY DET Back to Search Results
Model Number 236354REG
Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2019
Event Type  malfunction  
Event Description
Lap sponge with loose shredding fibers.
 
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Brand Name
REGARD
Type of Device
SPONGE LAP X-RAY DET
Manufacturer (Section D)
DUKAL CORPORATION
ronkonkoma NY
Manufacturer Contact
cheyenne stewart
645 maryville centre drive
ste 200
st. louis, MO 63141
MDR Report Key9454665
MDR Text Key194321735
Report Number3004513970-2019-00002
Device Sequence Number1
Product Code GDY
Combination Product (y/n)N
Reporter Country CodeUS
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 12/11/2019
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 Number236354REG
Device Catalogue Number236354REG
Device Lot NumberLK22018
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/05/2019
Event Location Hospital
Initial Date Manufacturer Received 08/05/2019
Initial Date FDA Received12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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