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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN WALGREENS; CRUTCH

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UNKNOWN WALGREENS; CRUTCH Back to Search Results
Model Number 783180
Device Problem Fracture (1260)
Patient Problems Fall (1848); Head Injury (1879)
Event Date 08/03/2020
Event Type  Injury  
Event Description
Drive devilbiss healthcare is the initial importer of the device which is a pair of crutches.The end-user does not want to return the device to us for evaluation.We will file an updated report when we have additional data.While in use the bottom half of the crutch split in half.The user fell.He injured his head, has a black eye, neck was bruised.He was taken to the hospital and was in the icu for 5 days.
 
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Brand Name
WALGREENS
Type of Device
CRUTCH
Manufacturer (Section D)
UNKNOWN
MDR Report Key10440196
MDR Text Key204083291
Report Number2438477-2020-00041
Device Sequence Number1
Product Code IPR
UDI-Device Identifier00311917203164
UDI-Public311917203164
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number783180
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/21/2020
Distributor Facility Aware Date08/13/2020
Event Location Home
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age78 YR
Patient Weight102
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