MAUDE MDR 336894

MDR report key: 336894
Report number: 1423507-2001-00169
Event key: 0
Event type: 3
Date received: 2001-06-13
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 500
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: PATRICIA SHARPE-GREGG
Address: 1430 WAUKEGAN RD MCGAW PARK IL 60085 US
Phone: 847-847-8475
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	INSTANT COLD PACK	COLD PACK	ALLEGIANCE HEALTHCARE CORP	IMF	10104	10104	UNK			N	Y	Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2001-06-13	0	1. O

Event Narratives#

D

Patient 1

EMPLOYEE SUSTAINED INJURY, USED ICE PACK & TOOK ICE PACK HOME. THE EMPLOYEE THEN REFROZE AND APPLIED TO RIGHT CALF AFTER SUSTAINING ANOTHER INJURY. THE PACK FELL DOWN TO ANKLE AREA AND THE EMPLOYEE SUSTAINED 3" X 4" MAROON DISCOLORATION TO SKIN. THE EMPLOYER RECOMMENDED THE EMPLOYEE SEEK MEDICAL ATTENTION REGARDING MATTER.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00888912022477	CHATTANOOGA	DJO, LLC	IMF	2023-01-04
00888912308441	CHATTANOOGA	DJO, LLC	IMF	2023-01-04
00888912042970	CHATTANOOGA	DJO, LLC	IMF	2022-03-31

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K900419	IMF	CRYOTRON-UL30	Henley Intl.	1990-02-27
510(k)	K871112	IMF	PELTIERTHERAPY(C) HEAT/COLD TREATMENT	Henley Intl.	1987-05-06

MAUDE MDR 336894

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#