MAUDE MDR 5860

MDR report key: 5860
Report number: 5860
Event key: 0
Event type: 3
Date of event: 1993-06-05
Date received: 1993-07-01
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
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1		CSF VENTRICULAR SHUNT	UNKNOWN	CAR						*		*

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	1993-07-01	0	1. *

Event Narratives#

D

Patient 1

CSF VALVE CLOTTED, REQUIRING REPLACEMENTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K920740	CAR	EPISENSOR PLUS	Industrias Palex C/O Dma Med-Chem Corp.	1994-03-07
510(k)	K926066	CAR	BION MUMPS-G ANTIBODY TEST SYSTEM	Bion Ent., Ltd.	1993-06-15
510(k)	K915577	CAR	IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE	Impra, Inc.	1992-03-11

MAUDE MDR 5860

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

Related PMN/PMA Records By Product Code#