MAUDE Adverse Event Report: UNKNOWN WALGREENS; CRUTCH

Model Number	783180
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.

• Brand Name: WALGREENS
• Common Device Name: CRUTCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10440196
• Report Number: 2438477-2020-00041
• Device Sequence Number: 11730655
• Product Code: IPR
• UDI-Device Identifier: 00311917203164
• UDI-Public: 311917203164
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2020
• Report Date (Section F): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 783180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/13/2020
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR
• Patient Weight: 102
• Date Report Sent to FDA: 08/21/2020