MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CANE, OFFSET, BLACK, ALUMINUM,

Catalog Number MDS86420

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

It was reported by the end user that he slipped and fell while he was ambulating on his recently painted cement porch.The end user stated it was raining outside and due to the wet surface, his cane tip slipped and he fell landing on his tailbone.The end user reported that he was able to get up with assistance of people nearby and was assisted back into the house without further incident.The end user stated that the next day he was in pain and he went to the emergency department for evaluation.The end user stated that x-rays were taken and he was diagnosed with a tailbone fracture.The emergency room physician prescribed the end user percocet and meloxicam for pain and the end user was discharged home the same day without further treatment.No additional information is available.The sample was not returned to the manufacturer for evaluation.A definitive root cause for the reported issue could not be determined at this time.There is no additional information available.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported the end user fell while ambulating with his cane and fractured his tailbone.

• Type of Device: CANE, OFFSET, BLACK, ALUMINUM,
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, il ; 6434960
• MDR Report Key: 9751856
• MDR Text Key: 186542536
• Report Number: 1417592-2020-00018
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 83