MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR, X-WIDE,HEAVY DUTY, 400 LBS.

Catalog Number MDS86800XW

Device Problems Break (1069); Crack (1135); Device Slipped (1584)

Patient Problem Injury (2348)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

It was initially reported from the medical supply company that a spoke on the wheel was broken which caused the end-user to fall out of the rollator.After follow up with the end-user, it was reported by the end-user, that the end-user was using the rollator to walk backwards out of the bathroom and the back right leg of the device popped out resulting in the end-user falling backwards onto the ground hitting the back of her head and her right shoulder.The end-user stated that she had to get help to get up off of the floor but did not call the paramedics or go to the hospital on the day of the fall.The end-user reported that she did follow up with her doctor a couple of days later during a scheduled follow-up appointment, and the doctor informed her that she could have a torn rotator cuff to her right shoulder, but the doctor does not want to do surgery at this time because the end-user has had numerous surgeries for a broken back and neck that she is currently recovering from.The end-user stated that her doctor gave her a prescription for ibuprofen 800mg and scheduled a follow up appointment.The medical supply company returned photographs of the wheel for evaluation and the customer reported issue of a cracked spoke on the wheel was confirmed; however the back right leg was intact and not disconnected.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was initially reported to the medical supply company that a spoke on the wheel was broken which caused the end-user to fall out of the rollator.After follow up with the end-user, it was reported by the end-user, that the end-user was using the rollator to walk backwards out of the bathroom and the back right leg of the device popped out resulting in the end-user falling backwards onto the ground hitting the back of her head and her right shoulder.The end-user stated that she had to get help to get up off of the floor but did not call the paramedics or go to the hospital on the day of the fall.The end-user reported that she did follow up with her doctor a couple of days later during a scheduled follow-up appointment, and the doctor informed her that she could have a torn rotator cuff to her right shoulder, but the doctor does not want to do surgery at this time because the end-user has had numerous surgeries for a broken back and neck that she is currently recovering from.The end-user stated that her doctor gave her a prescription for ibuprofen 800mg and scheduled a follow up appointment.The medical supply company returned photographs of the wheel for evaluation and the customer reported issue of a cracked spoke on the wheel was confirmed; however the back right leg was intact and not disconnected.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

• Type of Device: ROLLATOR, X-WIDE,HEAVY DUTY, 400 LBS.
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 8730737
• MDR Text Key: 149084285
• Report Number: 1417592-2019-00095
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86800XW
• Device Lot Number: 88518100004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Date Manufacturer Received: 05/28/2019
• 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: 59 YR
• Patient Weight: 98