VOSS PRONE POSITIONER P-3901

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-06-01 for VOSS PRONE POSITIONER P-3901 manufactured by Voss Medical Products.

Event Text Entries

[2769354] After long procedure, pt noted having "swelling" of nose and early signs of a pressure sore on nose.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2651311
MDR Report Key2651311
Report Source99
Date Received2009-06-01
Date of Report2009-06-01
Date of Event2009-04-22
Date Facility Aware2009-04-22
Report Date2009-04-22
Date Reported to Mfgr2009-05-14
Date Added to Maude2012-07-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVOSS PRONE POSITIONER
Generic NameHEAD REST
Product CodeKIL
Date Received2009-06-01
Model NumberP-3901
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Sequence No1
Device Event Key0
ManufacturerVOSS MEDICAL PRODUCTS
Manufacturer Address4235 CENTERGATE SAN ANTONIO TX 78217 US 78217


Patients

Patient NumberTreatmentOutcomeDate
10 2009-06-01

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