FDA.reportPublic FDA data

MAUDE MDR 1052

MDR report key
1052
Report number
2126677-1992-00001
Event key
0
Event type
3
Date of event
1991-03-19
Date received
1992-08-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
999
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWNX-RAY FILM PROCESSORUNKNOWNIXWUNKNOWNUNKNOWNN/AN*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-08-0401. R

Event Narratives#

D

Patient 1

IT WAS REPORTED TO GE THAT THE PLAINTIFF SLIPPED AND FELL IN SLIPPERY FLUID THAT LEAKED FROM THE X-RAY PROCESSOR.THIS INFORMATION PROVIDED TO GE IN THE FORM OF A SUMMONS. NO OTHER INFORMATION IS AVAILABLE AT THIS TIMEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.