MAUDE MDR 128595

MDR report key: 128595
Report number: MW1012370
Event key: 0
Event type: 3
Date of event: 1997-10-24
Date received: 1997-10-28
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 0
Event location: 3

Manufacturer Contact#

Report source: P
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	THERMOMETER	THERMOMETER, MERCURY	GENERAL MEDICAL CORP.	FLK	S01-06009018 AP058	211869	1-7 TEM-CON			N		Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	1997-10-28	0	1. O

Event Narratives#

D

Patient 1

THERMOMETER HAD AIR GAP IN MERCURY COLUMN THAT WOULD NOT "SHAKE DOWN". THE PRODUCT WAS REPLACED WITH NO KNOWN PT SEQUELAE.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00057475220495	BIOS Diagnostics	Thermor Ltd	FLK	2023-09-20
10057475220492	BIOS Diagnostics	Thermor Ltd	FLK	2023-09-20
04018674454681	Geratherm® classic	Geratherm Medical AG	FLK	2023-09-06
06972543480103	Disposable Thermometer Cover and Sheaths	KANG ZE INDUSTRIAL CO., LTD	FLK	2019-08-23
06972543480110	Disposable Thermometer Cover and Sheaths	KANG ZE INDUSTRIAL CO., LTD	FLK	2019-08-23
06972543480127	Disposable Thermometer Cover and Sheaths	KANG ZE INDUSTRIAL CO., LTD	FLK	2019-08-23
00614801200103	GERATHERM MERCURY FREE GLASS THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
00614801200417	GERATHERM MAGNATHERM MERCURY CLINICAL FREE GLASS THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
00614801200516	GERATHERM MERCURY FREE GLASS THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
00614801200615	Geratherm	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
00614801400701	GERATHERM MERCURY FREE GLASS HYPOTHYROID THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
20614801200107	GERATHERM MERCURY FREE GLASS THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
00614801200301	GERATHERM MERCURY FREE GLASS ORAL THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
00614801200400	GERATHERM MAGNATHERM MERCURY FREE GLASS THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
20614801200411	GERATHERM MAGNATHERM MERCURY CLINICAL FREE GLASS THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
00614801200509	GERATHERM MERCURY FREE GLASS THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
20614801200510	GERATHERM MERCURY FREE GLASS THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
00614801200608	GERATHERM MERCURY FREE BASAL GLASS THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
20614801200619	Geratherm	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01
60614801400703	GERATHERM MERCURY FREE GLASS HYPOTHYROID THERMOMETER	R.G. ENTERPRISES (U.S.A.), INC.	FLK	2016-09-01

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K960185	FLK	AMSINO CLINICAL THERMOMETER	Amsia Intl., Inc.	1996-03-28
510(k)	K960224	FLK	GERATHERM MERCUIRY FREE CLINICAL THERMOMETER	Rg Ent., Inc.	1996-03-25
510(k)	K953465	FLK	KENTEMP	Kentron Health Care, Inc.	1995-12-15
510(k)	K942483	FLK	CLINICAL GLASS THERMOMETER	Makol Medical Instruments Corp.	1995-03-28
510(k)	K941673	FLK	MEDIAID UNIVERSAL THERMOMETER	Polymedica Industries, Inc.	1994-08-25

MAUDE MDR 128595

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

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