ATL CAMERA DRAPE (PRODUCT #2950-1153-01)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-06 for ATL CAMERA DRAPE (PRODUCT #2950-1153-01) manufactured by Microtek Medical.

Event Text Entries

[20430512] Saline solution leaked out of seam between latex and polyethylene sleeve. Saline dripped into patients chest cavity. Customer claims only a small amout of saline was used and that dripping occurred immediately.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1043582-1998-00004
MDR Report Key180881
Date Received1998-08-06
Date of Report1998-07-14
Device Manufacturer Date1998-03-01
Date Added to Maude1998-08-07
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATL CAMERA DRAPE (PRODUCT #2950-1153-01)
Generic NameULTRA SOUND PROBE DRAPE
Product CodeKXX
Date Received1998-08-06
Returned To Mfg1998-07-15
Model NumberNA
Catalog Number2950-1153-01
Lot NumberD8079R
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key175898
ManufacturerMICROTEK MEDICAL
Manufacturer Address512 LEHMBERG RD. COLUMBUS MS 39702 US
Baseline Brand NameATL CAMERA DRAP (PRODUCT #2950-1153-01)
Baseline Generic NameULTRA SOUND PROBE DRAPE
Baseline Model NoNA
Baseline Catalog No2950-1153-01
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-08-06

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