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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN, INC. TRIMLINE BLOOD PRESSURE CUFF

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WELCH ALLYN, INC. TRIMLINE BLOOD PRESSURE CUFF Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Bruise/Contusion (1754); Injury (2348)
Event Date 12/18/2015
Event Type  malfunction  
Event Description
Trimline disposable bp cuffs are routinely causing friction injuries and bruising to patients' arms. Plastic liner on bp cuffs is adhering to skin and pinching, resulting in purple lined bruises and/or shearing of skin.
 
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Brand NameTRIMLINE
Type of DeviceBLOOD PRESSURE CUFF
Manufacturer (Section D)
WELCH ALLYN, INC.
4341 state street road
skaneateles falls NY 13153
MDR Report Key5353047
MDR Text Key35322711
Report Number5353047
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2016
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/06/2016
Event Location Hospital
Date Report to Manufacturer01/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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