MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,BASIC,BURGUNDY

Catalog Number MDS86850E

Device Problem Device Slipped (1584)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/13/2021

Event Type  Injury  

Manufacturer Narrative

It was reported; "the screw fell out of the rollator and the end user fell and broke their tail bone.The customer stated that the screw never stayed tight on the rollator they've been loose since she had the rollator." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported incident, medical intervention and in an abundance of caution, a med watch is being filed.The sample has not been return to medline for evaluation.Without the sample, a root cause will be difficult or impossible to determine.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.

Event Description

It was reported; "the screw fell out of the rollator and the end user fell and broke their tail bone.".

• Type of Device: ROLLATOR,BASIC,BURGUNDY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12584256
• MDR Text Key: 277719356
• Report Number: 1417592-2021-00176
• 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
• Report Date: 10/06/2021

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: MDS86850E
• Device Lot Number: 88520100004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 105