FDA.reportPublic FDA data

MAUDE MDR 9117

MDR report key
9117
Report number
9117
Event key
0
Event type
3
Date of event
1994-07-19
Date received
1994-10-03
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
1DRAINAGE FECAL INCONTINENCE COLLECTORDRAINAGE FECAL INCONTINENCE COLLECTORHOLLISTERKGY982198214D222NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-10-0301. O

Event Narratives#

D

Patient 1

FECAL INCONTINENCE COLLECTOR APPLIED 9/29/94. REMOVED BECAUSE OF LEAKAGE. PT NOW HAS PARTIAL-THICKNESS RED, MOIST, OPEN AREAS: LEFT BUTTOCK 2.5 X 1.5 CM AND RIGHT BUTTOCK 11 X 1-3.5 CM. RPTR APPLIED DEVICE. STAFF REMOVED DEVICE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. 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: OTHER. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.