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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORASURE TECHNOLOGIES INC. ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

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ORASURE TECHNOLOGIES INC. ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 02/17/2015
Event Type  Injury  
Event Description
An insurance agency swabbed a client with the orasure hiv-1 oral specimen collection device.The next day, the client reported that she developed multiple, painful blisters in her mouth where the pad made contact.
 
Manufacturer Narrative
The client works for a doctor's office.The doctor from that office saw her and prescribed a medication.
 
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Brand Name
ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Type of Device
ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
ORASURE TECHNOLOGIES INC.
220 east first street
bethlehem PA 18015
Manufacturer (Section G)
ORASURE TECHNOLOGIES INC.
220 east first street
bethlehem PA 18015
Manufacturer Contact
jose rosado
220 east first street
bethlehem, PA 18015
6108821820
MDR Report Key4623258
MDR Text Key5588934
Report Number3004142665-2015-00001
Device Sequence Number1
Product Code MVZ
Combination Product (y/n)N
PMA/PMN Number
BP910001
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 03/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/18/2015
Initial Date FDA Received03/18/2015
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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