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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AQUATEC OPERATIONS GMBH RAISED TOILET SEAT 9153651321; ADAPTOR, HYGIENE
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AQUATEC OPERATIONS GMBH RAISED TOILET SEAT 9153651321; ADAPTOR, HYGIENE Back to Search Results
Model Number H720T
Device Problems Bent (1059); Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The product was returned to invacare (b)(6).However, no evaluation was available for review at the time of this investigation.Mdr is being submitted as a result of a retrospective complaint review.
 
Event Description
The frame is bent and the arm rest assembly has broken off of the unit.
 
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Brand Name
RAISED TOILET SEAT 9153651321
Type of Device
ADAPTOR, HYGIENE
Manufacturer (Section D)
AQUATEC OPERATIONS GMBH
alemannenstrasse 10
isny 88316
GM  88316
Manufacturer (Section G)
AQUATEC OPERATIONS GMBH
alemannenstrasse 10
isny 88316
GM   88316
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5758520
MDR Text Key49246070
Report Number3007231105-2016-00092
Device Sequence Number1
Product Code ILS
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 02/16/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberH720T
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2012
Is the Reporter a Health Professional? No
Date Manufacturer Received02/16/2012
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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