TPLC - Total Product Life Cycle

• Device: thermometer, electronic, clinical
• Product Code: FLL
• Regulation Number: 880.2910
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACTHERM, INC.
	SUBSTANTIALLY EQUIVALENT	3
AGELESS HEALTH INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
AION BIOSYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
ALICN MEDICAL (SHENZHEN), INC
	SUBSTANTIALLY EQUIVALENT	1
ALICN MEDICAL SHENZHEN, INC
	SUBSTANTIALLY EQUIVALENT	3
ALICN MEDICAL SHENZHEN, INC.
	SUBSTANTIALLY EQUIVALENT	2
ALICN MEDICAL SHENZHEN,INC
	SUBSTANTIALLY EQUIVALENT	1
AMPEROR-ELECTRONIC(SZ) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ANDON HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
ARC DEVICES LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ARIZANT HEALTHCARE INC.
	SUBSTANTIALLY EQUIVALENT	1
AVITA CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOCARE ASIA CORPORATION LTD.
	SUBSTANTIALLY EQUIVALENT	2
BIOLAND TECHNOLOGY LTD
	SUBSTANTIALLY EQUIVALENT	1
BIOLAND TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	2
BLUE SPARK TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	2
BODYCAP
	SUBSTANTIALLY EQUIVALENT	1
BRAIN TUNNELGENIX TECHNOLOGIES CORP
	SUBSTANTIALLY EQUIVALENT	1
BROADMASTER BIOTECH, CORP.
	SUBSTANTIALLY EQUIVALENT	2
CADI SCIENTIFIC PTE.LTD
	SUBSTANTIALLY EQUIVALENT	1
CHANGSHAN ESTAR ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHINA SHENYANG MED-LAND IMP/EXP CORP., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CIRCA SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
CIRCA SCIENTIFIC, LLC
	SUBSTANTIALLY EQUIVALENT	2
COMPER CHUANGXIANG (BEIJING) TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
CONMO ELECTRONIC COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CONTEC MEDICAL SYSTEMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
COTRONIC MANUFACTURING
	SUBSTANTIALLY EQUIVALENT	1
COTRONIC TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIGIO2 INTERNATIONAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN E-TEST TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD.
	SUBSTANTIALLY EQUIVALENT	2
DONGGUAN XINTAI INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DRAEGER MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
DUTECK INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
E-CARE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
E-CARE TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EASYWELL BIOMEDICALS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ECH (CHANGZHOU) MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FAMIDOC TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
FAMIDOC TECHNOLOGY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FIAB SPA
	SUBSTANTIALLY EQUIVALENT	3
FORA CARE INC.
	SUBSTANTIALLY EQUIVALENT	1
FUDAKANG INDUSTRIAL CO LTD
	SUBSTANTIALLY EQUIVALENT	1
FUDAKANG INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
FUDAKANG INDUSTRIES CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
GEON CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GUANDONG GENIAL TECHNOLOGY CO., LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG BIOLIGHT MEDITECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG GENIAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU BERRCOM MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
GUANGZHOU BOSMA TECHNOLOGY CO LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU JINXINBAO ELECTRONIC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HADLEIGH HEALTH TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU HUA'AN MEDICAL&HEALTH INSTRUMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU HUA'AN MEDICAL&HEALTH INSTRUMENTS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU QINGYUAN MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU UNIVERSAL ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HARVARD MEDICAL DEVICES LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEALTH & LIFE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HEITAIDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HETAIDA TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HETAIDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
HONSUN (NANTONG) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HUAIAN ZHONGXIN PACKING MATERIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUBDIC CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
HUBDIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUNAN HONGGAO ELECTRONIC TECHNOLOFY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOCHIPS TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTELLIWORKS LLC
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL REGULATORY CONSULTANTS, LLC (IRC)
	SUBSTANTIALLY EQUIVALENT	1
INTRINITY GLOBAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
IWEECARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIAXING SHANGJIA INTELLIGENCE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JINXINBAO ELECTRONIC CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
JKH HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JKH USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
JOINSOON ELECTRONICS MFG CO LTD
	SUBSTANTIALLY EQUIVALENT	2
JOYTECH HEALTHCARE CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
JOYTECH HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
JOYTECH HEALTHCARE CO.,LTD
	SUBSTANTIALLY EQUIVALENT	2
K-JUMP HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	6
KANG ZE INDUSTRIAL CO. LIMITED
	SUBSTANTIALLY EQUIVALENT	1
KANGFU MEDICAL EQUIPMENT FACTORY
	SUBSTANTIALLY EQUIVALENT	2
KANGZHAN COMMUNICATION ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC)
	SUBSTANTIALLY EQUIVALENT	1
KAZ USA, INC (A SUBSIDIARY OF KAZ INC)
	SUBSTANTIALLY EQUIVALENT	2
KAZ USA, INC (A SUBSIDIARYOF KAZ INC)
	SUBSTANTIALLY EQUIVALENT	1
KAZ USA, INC., A HELEN OF TROY COMPANY
	SUBSTANTIALLY EQUIVALENT	7
KAZ, INC.
	SUBSTANTIALLY EQUIVALENT	1
KINGTECH ENTERPRISE, LTD.
	SUBSTANTIALLY EQUIVALENT	3
KINSA, INC.
	SUBSTANTIALLY EQUIVALENT	2
LIFE SCIENCE TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
LONGNAN RENZHONG MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MASIMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEASURE TECHNOLOGY CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDIANA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDISIM LTD.
	SUBSTANTIALLY EQUIVALENT	3
MEDIVANCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
METKO MEDIKAL VE TTBBI CIHAZLAR D1S TICARET LTD. STI
	SUBSTANTIALLY EQUIVALENT	1
MICROFILE INTELLECTUAL PROPERTY GMBH
	SUBSTANTIALLY EQUIVALENT	1
MICROLIFE INTELLECTUAL PROPERTY GMBH
	SUBSTANTIALLY EQUIVALENT	9
NEXMED TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
NINGBO RANOR MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
OMRON HEALTHCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORANTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS ELECTRONICS UK LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PHOENIX INNOVATIVE HEALTHCARE MANUFACTURERS PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
PINGHU SAMA MEDICAL PACKING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PUTIAN HANJIANG HUAFENG PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO YASEE MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RADIANT INNOVATION INC.
	SUBSTANTIALLY EQUIVALENT	4
RADIANT INNOVATION, INC.
	SUBSTANTIALLY EQUIVALENT	3
RAIING MEDICAL COMPANY
	SUBSTANTIALLY EQUIVALENT	1
RALING MEDICAL COMPANY
	SUBSTANTIALLY EQUIVALENT	1
RIO FLEXON TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RUDOLF RIESTER GMBH
	SUBSTANTIALLY EQUIVALENT	1
RYCOM ELECTRON TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SECURUS MEDICAL GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
SECURUS,INC
	SUBSTANTIALLY EQUIVALENT	1
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SENSATRONIC GMBH
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG BITTEL INTELLIGENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHEN ZHEN RONG FENG TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN AEON TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN AOJ MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN BRAV ELECTRONIC TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CALIBEUR INDUSTRIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CHANGKUN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN COMBEI TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ENVISEN INDUSTRY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN FINICARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JIACOM TECHNOLOGY CO ., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JIACOM TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JUMPER MEDICAL EQUIPMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JUZHONG TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN LAUNCH ELECTRICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN LEPU INTELLIGENT MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN PANGO ELECTRONIC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PANGO MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SONIDA DIGITAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN URION TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN XUNWEI INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN YI FANG BLISTER PACKAGING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN YOLANDA TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SICHUAN YOUKEDE MEDICAL EQUIPMENT CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SMART TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STARBOARD MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
STETHOCLOUD PTY. LTD (CLINICLOUD)
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU MELODICARE MEDICAL TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
T&R BIOFAB CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAIDOC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	11
TECNIMED S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
THERMOMEDICS INC.
	SUBSTANTIALLY EQUIVALENT	1
TRUER MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
TRULY INSTRUMENT LIMITED
	SUBSTANTIALLY EQUIVALENT	2
TYTO CARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNI-TREND TECHNOLOGY (CHINA) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNI-TREND TECHNOLOGY(CHINA) CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
UNIMED MEDICAL SUPPLIES INC.
	SUBSTANTIALLY EQUIVALENT	1
VALEO CORP.
	SUBSTANTIALLY EQUIVALENT	1
VEGA TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VISIOMED GROUP SA
	SUBSTANTIALLY EQUIVALENT	1
VIVALNK INC.
	SUBSTANTIALLY EQUIVALENT	2
WELLO, INC
	SUBSTANTIALLY EQUIVALENT	1
WELLVII INC
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU YOSUN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WITHINGS
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN ACURIO INSTRUMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN ANTS BRO TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
XIAMEN INTRETECH INC.
	SUBSTANTIALLY EQUIVALENT	1
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
YIBIN JUNXIN ELECTRONICS TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YU LONG SHENG TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZHANGZHOU EASEPAL MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG RONGSHENG INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHONGSHAN JINLI ELECTRONIC WEIGHING  EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUHAI YUEJA MEDICAL DEVICE TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUZHOU GOLDENHOT MEDICAL TECHNOLOGY CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	54	54
2015	53	53
2016	58	58
2017	118	118
2018	51	51
2019	52	52
2020	53	53
2021	115	115
2022	142	142
2023	101	101
2024	21	21

Device Problems	MDRs with this Device Problem	Events in those MDRs
Excessive Heating	257	257
False Negative Result	149	149
Adverse Event Without Identified Device or Use Problem	84	84
Insufficient Information	73	73
Incorrect, Inadequate or Imprecise Result or Readings	50	50
Low Readings	42	42
Power Problem	34	34
Battery Problem	29	29
Product Quality Problem	28	28
Nonstandard Device	27	27
Low Test Results	27	27
Device Operates Differently Than Expected	24	24
Use of Device Problem	22	22
Device Issue	22	22
Invalid Sensing	16	16
High Readings	15	15
Improper or Incorrect Procedure or Method	14	14
Incorrect Measurement	13	13
Patient Device Interaction Problem	10	10
Break	10	10
Thermal Decomposition of Device	9	9
Appropriate Term/Code Not Available	9	9
False Reading From Device Non-Compliance	9	9
Device Reprocessing Problem	8	8
Output Problem	7	7
Temperature Problem	6	6
Manufacturing, Packaging or Shipping Problem	6	6
High Test Results	6	6
Overheating of Device	5	5
Defective Device	4	4
Unable to Obtain Readings	4	4
Low Sensing Threshold	4	4
Detachment Of Device Component	4	4
Difficult to Remove	4	4
Device Sensing Problem	4	4
Defective Component	3	3
False Positive Result	3	3
Burst Container or Vessel	3	3
Material Fragmentation	3	3
Device Emits Odor	3	3
Difficult to Insert	3	3
Device Damaged Prior to Use	3	3
Detachment of Device or Device Component	3	3
Display or Visual Feedback Problem	2	2
Calibration Problem	2	2
Labelling, Instructions for Use or Training Problem	2	2
Loose or Intermittent Connection	2	2
Erratic or Intermittent Display	2	2
Device Alarm System	2	2
Entrapment of Device	2	2
Failure to Power Up	2	2
Device Handling Problem	2	2
Loss of Power	2	2
Material Separation	2	2
Migration or Expulsion of Device	2	2
Device Operational Issue	2	2
Contamination	2	2
Improper Device Output	2	2
Contamination /Decontamination Problem	2	2
Explosion	2	2
No Apparent Adverse Event	2	2
No Display/Image	2	2
Component Missing	2	2
Melted	2	2
Smoking	1	1
Structural Problem	1	1
Electromagnetic Compatibility Problem	1	1
Intermittent Continuity	1	1
Output below Specifications	1	1
Extrusion	1	1
Device Displays Incorrect Message	1	1
Display Difficult to Read	1	1
Application Interface Becomes Non-Functional Or Program Exits Abnormally	1	1
Device Fell	1	1
Failure To Adhere Or Bond	1	1
Material Integrity Problem	1	1
Failure to Advance	1	1
Human-Device Interface Problem	1	1
Sparking	1	1
Application Program Problem	1	1
Positioning Failure	1	1
Off-Label Use	1	1
Fail-Safe Design Failure	1	1
Leak/Splash	1	1
Failure to Clean Adequately	1	1
Device Contamination with Chemical or Other Material	1	1
Incomplete or Inadequate Connection	1	1
Fitting Problem	1	1
Computer Software Problem	1	1
Difficult or Delayed Activation	1	1
Calibration Error	1	1
Malposition of Device	1	1
Moisture or Humidity Problem	1	1
Noise, Audible	1	1
Incorrect Or Inadequate Test Results	1	1
Missing Value Reason	1	1
Fluid/Blood Leak	1	1
Packaging Problem	1	1
Low Audible Alarm	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	264	264
Fever	231	231
No Known Impact Or Consequence To Patient	125	125
No Consequences Or Impact To Patient	35	35
Seizures	25	25
No Code Available	23	23
Insufficient Information	16	16
No Information	15	15
No Patient Involvement	12	12
Foreign Body In Patient	8	8
Misdiagnosis	8	8
Patient Problem/Medical Problem	6	6
Superficial (First Degree) Burn	6	6
Perforation	6	6
Unspecified Infection	5	5
Alteration In Body Temperature	5	5
Blood Loss	5	5
Injury	5	5
Alteration in Body Temperature	5	5
Missing Value Reason	4	4
Burn(s)	4	4
Bacterial Infection	4	4
Hemorrhage/Bleeding	3	3
Hypothermia	3	3
Burning Sensation	3	3
Device Embedded In Tissue or Plaque	3	3
Laceration(s) of Esophagus	3	3
Complaint, Ill-Defined	2	2
Caustic/Chemical Burns	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Convulsion/Seizure	2	2
Pain	2	2
Anxiety	2	2
Distress	2	2
Death	2	2
Pneumonia	2	2
Fistula	2	2
Gastritis	2	2
Hematoma	1	1
Bronchitis	1	1
Arrhythmia	1	1
Asthma	1	1
High Blood Pressure/ Hypertension	1	1
Low Blood Pressure/ Hypotension	1	1
Cardiopulmonary Arrest	1	1
Irritation	1	1
Laceration(s)	1	1
Miscarriage	1	1
Nausea	1	1
Oversedation	1	1
Sepsis	1	1
Skin Discoloration	1	1
Tachycardia	1	1
Vomiting	1	1
Discomfort	1	1
Rupture	1	1
Viral Infection	1	1
Sinus Perforation	1	1
Bronchial Hemorrhage	1	1
Epistaxis	1	1
Gastroesophageal Burn	1	1
Unspecified Gastrointestinal Problem	1	1
Unspecified Kidney or Urinary Problem	1	1
Blister	1	1
Partial thickness (Second Degree) Burn	1	1
Test Result	1	1
Full thickness (Third Degree) Burn	1	1
Abdominal Distention	1	1
Malaise	1	1
Perforation of Esophagus	1	1
Choking	1	1
Nasal Obstruction	1	1
Shaking/Tremors	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Nov-18-2017
2	Bestmed, LLC	II	Dec-16-2015
3	Cardinal Health 200, LLC	II	Feb-04-2020
4	Measurement Specialties Inc	II	Jan-19-2018
5	Philips Consumer Lifestyle	II	Feb-22-2018
6	Vital Signs Devices, a GE Healthcare Company	II	Aug-13-2013
7	Walgreen Company	II	Jan-11-2012
8	Welch Allyn Inc	II	Sep-16-2021