Alarm, Conditioned Response Enuresis
Gastroenterology, Urology · 21 CFR 876.2040
Recent MDR events
965 adverse event reports on file
- CENTRELLA WITH WATCHCAREOct 11, 2022MalfunctionHill-rom, Inc.MW5112537
- ULTIMATE PRO BEDWETTING ALARMSep 15, 2020InjuryMalem Medical Ltd.MW5096669
- BEDWETTING ALARM DEVICEAug 6, 2020InjuryMalem Medical, Ltd.MW5095948
- BED WETTING ALARMJul 2, 2020InjuryMalem Medical LtdMW5095349
- BEDWETTING ALARMJun 25, 2020InjuryMalem Medical Ltd.MW5095218
- BEDWETTING ALARMJun 23, 2020InjuryMalem Medical Ltd.MW5095181
- MALEMJun 16, 2020InjuryMalem Medical, Ltd.MW5095029
- MALEM BEDWETTING ALARMJun 5, 2020InjuryMalem Medical Ltd.MW5094871
- BED WETTING ALARMMay 29, 2020InjuryMalem Medical Ltd.MW5094758
- BEDWETTING ENURESIS ALARMMay 12, 2020InjuryMalem Medical Ltd.MW5094466
Event type breakdown
Recalls
4 recall events for this product code
- Baxter Healthcare CorporationOpen, ClassifiedOct 31, 2022
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
Z-0142-2023 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedOct 31, 2022
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
Z-0143-2023 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedOct 31, 2022
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
Z-0144-2023 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedOct 31, 2022
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
Z-0145-2023 · View FDA record ↗
Registered firms
20 firms currently registered for this product code
Shantou City Kin Seng Plastic Co., Ltd.
GUANGDONG, CN
Medline Industries, Lp - Northfield
Northfield, IL, US
Cordica Medical, Inc. (formally Team Technologies, Inc.)
MORRISTOWN, TN, US
Malem Medical Ltd
NOTTINGHAM Nottinghamshire, GB
Theos Medical Systems, Inc.
Santa Clara, CA, US
Wicked Sheets D/b/a Wicked Technologies
Louisville, KY, US
Dr Sagi Yaacov Ltd
haifa Northern, IL
Note Herrljunga Ab
Herrljunga Vastra Gotaland, SE
Foshan Rm Products Co., Ltd
Foshan Guangdong, CN
Pottymd, Llc
KNOXVILLE, TN, US
Rodger B.v.
Ravenstein Noord-Brabant, NL
Rosti Integrated Manufacturing Solutions (suzhou) Co., Ltd.
Suzhou Jiangsu, CN
Marvelworks Ltd.
Chai Wan, HK
Essity Hygiene And Health Ab
Gothenburg Vastra Gotaland, SE
Essity Operations Gennep B.v.
GENNEP Limburg, NL
Providence Enterprise Limited
Shenzhen Guangdong, CN
Anzacare Ltd.
Waikanae Wellington, NZ
Seneca Sense Technologies Inc
Montreal Quebec, CA
Essity Slovakia S.r.o.
GEMERSKA-HORKA Kosicky, SK
510(k) clearances
37 clearances for this product code
- Simavita Pty LimitedAug 22, 2013
K130951 · SIM
- Humed, Inc.Jan 8, 1998
K971442 · HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5
- Digital Applications, Inc.Aug 18, 1997
K971855 · POTTY PAL AND FOREVER-DRY
- Princeton Regulatory Assoc.Aug 1, 1996
K962770 · UROSURGE ACUTRAINER
- Bio-Systems ResearchJul 22, 1996
K962416 · DRYTIME FOR BLADDER CONTROL SILENT
- Health Sense Intl., Inc.Mar 12, 1996
K955338 · DRYTIME FOR POTTY TRAINING
- Health Sense Intl., Inc.May 24, 1995
K943558 · PRO'TECT
- Health Sense Intl., Inc.May 24, 1995
K943559 · REMOTE A'LERT