FDA.reportPublic FDA data

MAUDE MDR 3476

MDR report key
3476
Report number
3476
Event key
0
Event type
3
Date of event
1992-05-31
Date received
1992-07-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SWAN NECK MISSOURI PERTIONEAL DIALYSIS CATHETER - LEFTCAPD CATHETERACCURATE SURGICAL INSTRUMENT COMPANYFKOUNKNOWNSNM 2 - LEFTHX70 - 12 - 30YY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-07-3101. O

Event Narratives#

D

Patient 1

PATIENT HAD CAPD CATH PLACED 5/19/92. RETURNED TO HEALTH TO HEALTH CENTER 5/31/92 WITH POSSIBLE INFECTED CATHETER. WAS TAKEN TO OR FOR REMOVAL OF CATHETER. ANTIBIOTICS GIVEN. DISCHARGE DIAGNOSIS STATED MALFUNCTIONING VASCULAR CAPD CATHETER.DEVICE 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. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.