MAUDE Adverse Event Report: REMOVED INDUSTRIAL CO., LTD. DRIVE MEDICAL; CRUTCH

Device Problem Device Issue (2379)

Patient Problem Injury (2348)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

Please note that this submission package was originally submitted on 12/31/2015 using the test site because i was unaware of the production site.It will be repackage and send through the production site on 03/09/2016.

Event Description

Drive medical received a notice from a provider regarding an incident which involves the crutch which drive medical imports and distributes.On the third use of the crutch, the base/foot metal was sticking through which was brought by an allegedly worn out tips.As a result, the end user lost her balance and fell to the floor.She went to the hospital and had an mri done wherein the result shows she has a torn right achilles.This report is based on information provided by the end user and the provider.

• Brand Name: DRIVE MEDICAL
• Type of Device: CRUTCH
• Manufacturer (Section D): REMOVED INDUSTRIAL CO., LTD.; north side of no.6 tech road; high & new technology zone; heyuan city, guangdong 51700 0; CH 517000
• MDR Report Key: 5489651
• MDR Text Key: 39986846
• Report Number: 2438477-2015-00037
• 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: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/31/2015,12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2015
• Distributor Facility Aware Date: 12/02/2015
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 12/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR