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MAUDE Adverse Event Report: UNKNOWN CRUTCH; 890.3150
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UNKNOWN CRUTCH; 890.3150
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Model Number
8115-A
Device Problem
Detachment Of Device Component (1104)
Patient Problem
No Consequences Or Impact To Patient (2199)
Event Type
No Answer Provided
Event Description
End user states that the piece at the bottom of the crutch, that holds the 3 pieces together, keeps coming off.
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Brand Name
CRUTCH
Type of Device
890.3150
Manufacturer
(Section D)
UNKNOWN
OH
MDR Report Key
4062592
MDR Text Key
4852505
Report Number
1531186-2014-03828
Device Sequence Number
1
Product Code
IPS
Combination Product (y/n)
N
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Manufacturer
Source Type
Invalid Data
Reporter Occupation
Patient
Type of Report
Initial
Report Date
09/04/2014,08/12/2014
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
Lay User/Patient
Device Model Number
8115-A
Was Device Available for Evaluation?
No
Is the Reporter a Health Professional?
No
Was the Report Sent to FDA?
Yes
Date Report Sent to FDA
09/04/2014
Distributor Facility Aware Date
08/12/2014
Date Report to Manufacturer
09/04/2014
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
09/05/2014
Is This a Reprocessed and Reused Single-Use Device?
No
Patient Sequence Number
1
Patient Outcome(s)
Other;
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