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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 151-R SKINMARKER RULER; MARKER, SKIN
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COVIDIEN 151-R SKINMARKER RULER; MARKER, SKIN Back to Search Results
Model Number 31145892
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2019
Event Type  malfunction  
Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event Description
Customer reports that the ink leaked from the cap of the marker.
 
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Brand Name
151-R SKINMARKER RULER
Type of Device
MARKER, SKIN
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
Manufacturer (Section G)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX   22500
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key9369358
MDR Text Key169249018
Report Number9612030-2019-02365
Device Sequence Number1
Product Code FZZ
UDI-Device Identifier10884521208742
UDI-Public10884521208742
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number31145892
Device Catalogue Number31145892
Device Lot Number6306108964
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/21/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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