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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDISAFE UK LTD. INNOWAVE PRO SONIC IRRIGATOR; DISINFECTOR

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MEDISAFE UK LTD. INNOWAVE PRO SONIC IRRIGATOR; DISINFECTOR Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2020
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived on site to inspect the unit.During the inspection of the unit, the technician found that the hose connecting into the pressure port had split, allowing water to leak through and the reported event to occur.To resolve the issue, the technician replaced the hose connecting into the pressure port, tested the unit and found it to be operational.The unit was returned to service.A 3 year complaint review reveals this to be an isolated occurrence.No additional issues have been reported.
 
Event Description
The user facility reported water leaking from their innowave pro sonic irrigator.No report of injury.
 
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Brand Name
INNOWAVE PRO SONIC IRRIGATOR
Type of Device
DISINFECTOR
Manufacturer (Section D)
MEDISAFE UK LTD.
unit 7 & 8, dunmow road
bishop stortford
hertforshire, CM23 5GZ
UK  CM23 5GZ
Manufacturer (Section G)
MEDISAFE UK LTD.
unit 7 & 8, dunmow road
bishop stortford
hertforshire, CM23 5GZ
UK   CM23 5GZ
Manufacturer Contact
daniel davy
5960 heisley road
mentor, oh 
3927453
MDR Report Key9948318
MDR Text Key199693390
Report Number9617134-2020-00001
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2020
Initial Date FDA Received04/10/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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