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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROTEK DOMINICANA, S.A. DRAPE ARMOUR RADIATION PROTECTION

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MICROTEK DOMINICANA, S.A. DRAPE ARMOUR RADIATION PROTECTION Back to Search Results
Model Number RBFPS101L
Device Problem Material Disintegration (1177)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The dhr was reviewed for lot d160121. This lot had (b)(4) pcs and was manufactured on 01/14/2016 in combined shift. No defects related to the non conformance were observed during the quality inspection. Based on the review of the device history record, the non conformity doesn't appear to be the result of a personnel, process, or materials issue. No sample was received for evaluation.
 
Event Description
Customer stated that during a procedure the drape was saturated with blood and they were running a line back and forth over the pad in and out of the femoral access and the covering to the pad disintegrated. This was considered compromising to patient safety. No patient injury or treatment was reported for the incident.
 
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Brand NameDRAPE ARMOUR
Type of DeviceRADIATION PROTECTION
Manufacturer (Section D)
MICROTEK DOMINICANA, S.A.
zona franca no. 2
la romana,
DR
Manufacturer (Section G)
MICROTEK DOMINICANA
zona franca no. 2
la romana,
DR
Manufacturer Contact
jennifer mrkvicka
370 wabasha street north
st. paul, MN 55102
6512502237
MDR Report Key6301447
MDR Text Key66820378
Report Number8043817-2017-00003
Device Sequence Number1
Product Code KPY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRBFPS101L
Device Lot NumberD160121
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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