MAUDE Adverse Event Report: MEDLINE INDUSTRUIES LP; ROLLATOR, EMPOWER, BLUE

Catalog Number MDS86845BM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the end user was sitting on the rollator at his desk turning from the middle to the side and the wheel broke off resulting in the end user falling to the ground.According to the customer, when the end user fell on the floor he cut the left side of his head and his left hand.The customer's coworker took the end user to the emergency room and the end user received an unknown number of stitches to his left hand and the left side of his head.A ct scan was performed that was normal.No further incident or injury was reported.The stitches have since been removed with no follow up care required.The device has not been returned to the manufacturer for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be submitted.

Event Description

It was reported that the end user was sitting on the rollator at his desk turning from the middle to the side and the wheel broke off resulting in the end user falling to the ground and cutting his hand and his head.

Manufacturer Narrative

D9: sample available 11/09/3021.The sample was returned for evaluation.The customer reported issue of a wheel that broke off during use was confirmed through visual inspection of the received sample.The evaluation showed that the caster stem bolt was fractured and caster stem appears to be stripped.Based on the condition of the sample, the suspected root cause is the customer self-propelling in the device in a seated position against manufacturing instruction.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: ROLLATOR, EMPOWER, BLUE
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 12704508
• MDR Text Key: 278748119
• Report Number: 1417592-2021-00188
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

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: MDS86845BM
• Device Lot Number: 86720090005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Sex: Male
• Patient Weight: 77 KG