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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET PRONTO M41 BLUE BASE 9153645762; WHEELCHAIR, POWERED
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INVACARE TAYLOR STREET PRONTO M41 BLUE BASE 9153645762; WHEELCHAIR, POWERED Back to Search Results
Model Number M41
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The batteries are leaking which has caused property damage to the carpet.The pronto m41 is the same /similar to a product or products which are, or have been manufactured and/or marketed by invacare in u.S.The alleged incident occurred in the (b)(6).
 
Event Description
The batteries are leaking which has caused property damage to the carpet.The pronto m41 is the same /similar to a product or products which are, or have been manufactured and/or marketed by invacare in u.S.The alleged incident occurred in the (b)(6).
 
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Brand Name
PRONTO M41 BLUE BASE 9153645762
Type of Device
WHEELCHAIR, POWERED
Manufacturer (Section D)
INVACARE TAYLOR STREET
1200 taylor street
elyria OH 44036
Manufacturer (Section G)
INVACARE TAYLOR STREET
1200 taylor street
elyria OH 44036
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5428007
MDR Text Key38533192
Report Number1525712-2016-00464
Device Sequence Number1
Product Code ITI
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 02/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM41
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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