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MAUDE Adverse Event Report: ORTHOVISC INJ 15 MG/ML
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ORTHOVISC INJ 15 MG/ML
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Device Problem
Break (1069)
Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date
06/14/2016
Event Type
malfunction
Event Description
One of the heads of the syringe broke.I received 3 shipped and 1 broke.Diagnosis or reason for use: m17.9.
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Brand Name
ORTHOVISC INJ 15 MG/ML
Type of Device
ORTHOVISC INJ 15 MG/ML
MDR Report Key
5732871
MDR Text Key
47713810
Report Number
MW5062903
Device Sequence Number
1
Product Code
MOZ
UDI-Device Identifier
59676036001
UDI-Public
59676036001
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Pharmacist
Type of Report
Initial
Report Date
06/14/2016
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
No Information
Was Device Available for Evaluation?
No
Is the Reporter a Health Professional?
Yes
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
06/14/2016
Type of Device Usage
N
Patient Sequence Number
1
Patient Age
57 YR
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