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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
8120-A
Device Problems
Detachment Of Device Component (1104); Product Quality Problem (1506); Torn Material (3024)
Patient Problem
No Consequences Or Impact To Patient (2199)
Event Type
No Answer Provided
Event Description
Per complainant, hand grips crumbled apart.
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Brand Name
CRUTCH
Type of Device
890.3150
Manufacturer
(Section D)
UNKNOWN
OH
MDR Report Key
4105739
MDR Text Key
18365850
Report Number
1531186-2014-04310
Device Sequence Number
1
Product Code
IPR
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
Medical Equipment Company Technician/Representative
Type of Report
Initial
Report Date
09/22/2014,08/27/2014
1
Device was Involved in the Event
1
Patient was Involved in the Event
Date FDA Received
09/22/2014
Is this an Adverse Event Report?
No
Is this a Product Problem Report?
Yes
Device Operator
Lay User/Patient
Device Model Number
8120-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
09/22/2014
Distributor Facility Aware Date
08/27/2014
Date Report to Manufacturer
09/22/2014
Is This a Reprocessed and Reused Single-Use Device?
No
Patient Sequence Number
1
Patient Outcome(s)
Other;
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