MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,SUPER LIGHT,250LB CAP.

Catalog Number WRX449724

Device Problem Break (1069)

Patient Problem Joint Dislocation (2374)

Event Date 03/30/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that while end-user was at home sitting on the rollator, the right rear wheel broke resulting in the end-user falling onto and dislocating his right shoulder.Emergency medical service was called and "while the paramedic was picking me up, it (shoulder) went back in." per report, the end-user was transported to the emergency department where x-rays were done.The end-user stated that the x-rays revealed there was nothing broken and that no further medical intervention was required.The end-user was reportedly instructed to follow-up with an orthopedic doctor.At the time of the incident, it was denied that end-user was self-propelling while sitting.The rollator involved in this incident was reportedly used for approximately a year and a half.Due to the reported shoulder dislocation and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, supplemental medwatch will be filed.

Event Description

It was reported that the right rear wheel of the rollator broke resulting in the end-user falling and dislocating his shoulder.

Manufacturer Narrative

On 07/16/2019, additional information was received from the end-user.The end-user reported that approximately two months after the date of the incident ((b)(6) 2019), end-user was evaluated by an orthopedic specialist and he was told his rotator cuff was "badly damaged." the end-user reportedly underwent reverse shoulder replacement last (b)(6) 2019 and stayed in the hospital for two days.During follow-up, an x-ray of the affected area was obtained and reportably, "everything looks good." the end-user added that he remains undergoing physical therapy.The sample was returned for evaluation and the complaint of a broken wheel was confirmed.A potential root cause could be unintended use error resulting in bearing failure.The received rollator had signs of impact to the fork, where the broken wheel was attached.A definitive root cause 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,SUPER LIGHT,250LB CAP.
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8564631
• MDR Text Key: 143703633
• Report Number: 1417592-2019-00059
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: WRX449724
• Device Lot Number: 86715080013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 07/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 82