FDA.reportPublic FDA data

MAUDE MDR 271

MDR report key
271
Report number
271
Event key
0
Event type
3
Date of event
1992-01-28
Date received
1992-03-05
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
1UNKNOWNCAPD CATHETERUNKNOWNEZKUNKNOWNUNKNOWNUNKNOWNNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-03-0501. O

Event Narratives#

D

Patient 1

PATIENT ADMITTED TO HAVE CUFF OF CAPD CATHETER DEBRIDED;HAS INFECTION AROUND EXIT SITE OF CATHETER. CUFF TO BE DEBRIDED IN ATTEMPT TO SALVAGE CATHETER. PATIENT HAS BEEN ON CHRONIC ANTIBODICS IN ATTEMPT TO CONTROL INFECTION. TIP OF CUFF IS VISABLE THROUGH THE SKINDEVICE 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.