MAUDE Adverse Event Report: UNKNOWN WALGREENS; CRUTCH

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.

• Brand Name: WALGREENS
• Type of Device: CRUTCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10440196
• MDR Text Key: 204083291
• Report Number: 2438477-2020-00041
• Device Sequence Number: 1
• Product Code: IPR
• UDI-Device Identifier: 00311917203164
• UDI-Public: 311917203164
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: 783180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2020
• Distributor Facility Aware Date: 08/13/2020
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Weight: 102