HYDRATION STATION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-06-03 for HYDRATION STATION manufactured by Sybaritic, Inc..

Event Text Entries

[20331640] Temperature sensor failed while hydration station device was in operation causing unit to heat up warmer than normal maximum temperature and resulting in minor burning to users calves. Client did not seek medical attention and burning dissipated shortly thereafter. Temperature sensor was replaced on unit as a result of the incident.
Patient Sequence No: 1, Text Type: D, B5

[20597776] Na.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2135127-2009-00001
• MDR Report Key: 2651327
• Report Source: 06
• Date Received: 2009-06-03
• Date of Report: 2009-06-01
• Date of Event: 2009-05-04
• Date Facility Aware: 2009-05-04
• Report Date: 2009-06-01
• Date Reported to FDA: 2009-06-01
• Date Mfgr Received: 2009-05-04
• Device Manufacturer Date: 2006-04-01
• Date Added to Maude: 2012-07-12
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: VARBOLA MARJAMMA VALD
• Manufacturer City: RAPLAMMA 78203
• Manufacturer Country: EN
• Manufacturer Postal: 78203
• Manufacturer Phone: 372409006
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HYDRATION STATION
• Generic Name: DERMALIFE CAPSULE
• Product Code: IMB
• Date Received: 2009-06-03
• Device Availability: N
• Device Age: 37 MO
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SYBARITIC, INC.
• Manufacturer Address: BLOOMINGTON MN US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-06-03