ALLEN C-PRONE COMFORT MASK A-70310-A1 A-70310

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-11-17 for ALLEN C-PRONE COMFORT MASK A-70310-A1 A-70310 manufactured by Allen Medical.

Event Text Entries

[16834403] On (b)(6), 2009, an allen sales rep was contacted by a user facility with the report that a female pt had experienced a post-operative rash & bruising following a lengthy positioning case. It was later learned that the pt had developed a pressure ulcer on her chin following a 10-hour-long spinal surgery. Additional treatment is required to resolved this condition.
Patient Sequence No: 1, Text Type: D, B5


[17052855] Allen medical sent a qa mgr and the allen sales representative to the customer site for an investigation. On (b)(6) 2009, they observed a similar case at this facility during which the same device and products were used as on (b)(6) 2009. After watching the case, it is believed that the initial event likely resulted from improper positioning of the pt on the face mask, as the pt's chin was likely resting on the plastic chin bar of the c-prone head positioner instead of on the foam face mask. No device defects were found.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1221538-2009-00012
MDR Report Key1541454
Report Source06
Date Received2009-11-17
Date of Report2009-10-19
Date of Event2009-10-15
Date Mfgr Received2009-10-19
Date Added to Maude2011-03-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactNANCY ROYALTY, DIRECTOR
Manufacturer StreetONE POST OFFICE SQUARE
Manufacturer CityACTON MA 01720
Manufacturer CountryUS
Manufacturer Postal01720
Manufacturer Phone8885214277
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALLEN C-PRONE COMFORT MASK
Generic NameCOMFORT MASK
Product CodeNMC
Date Received2009-11-17
Model NumberA-70310-A1
Catalog NumberA-70310
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerALLEN MEDICAL
Manufacturer AddressACTON MA 01720 US 01720


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2009-11-17

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