PRONE POSITIONER P-39-01 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-05 for PRONE POSITIONER P-39-01 NA manufactured by Voss Medical Products.

Event Text Entries

[224912] Hospital purchasing agent contacted the co indicating that physicians at their hospital have experienced rare occasions when pts have had a pressure sore or excoriation of the chin and forehead. Purchasing agent did not have specific physicians' names, patients' names, dates or related information and was unable to provide any more info.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1643116-2001-00002
MDR Report Key326016
Date Received2001-04-05
Date of Report1994-10-05
Date of Event1994-10-01
Date Mfgr Received1994-10-05
Date Added to Maude2001-04-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactSTEVE HOLLOWAY
Manufacturer Street4227 CENTERGATE
Manufacturer CitySAN ANTONIO TX 78217
Manufacturer CountryUS
Manufacturer Postal78217
Manufacturer Phone2106503124
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRONE POSITIONER
Generic NameHEAD SUPPORT FOR PRONE SURGICAL PROCEDURES
Product CodeKIL
Date Received2001-04-05
Model NumberP-39-01
Catalog NumberNA
Lot NumberUNK
ID NumberNA
OperatorUNKNOWN
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key315469
ManufacturerVOSS MEDICAL PRODUCTS
Manufacturer Address4227 CENTERGATE SAN ANTONIO TX 78217 US
Baseline Brand NamePRONE POSITIONER
Baseline Generic NameHEAD SUPPORT FOR PHONE POSITION SURGERY
Baseline Model NoP-39-01
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK932187
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2001-04-05

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