MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; ROLLATOR, STEEL, KNOCK-DOWN

Catalog Number MDS86850ESKD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 04/19/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported by the end user, that a screw fell out of the rollator, causing her to fall and hit her head.The customer reported she was outside walking her dog, when she fell and hit her head on a fence and hurt her back.She reported she went to the hospital and had a ct scan that resulted in no concussion.She states she received an unspecified pain injection in her left hip, for her back pain.This is a reportable mdr event, related to the need for the unspecified pain medication.No sample has been returned for evaluation.A root cause for the reported incident was unable to be determined.If additional relevant information becomes available a supplemental mdr will be filed.

Event Description

It was reported by the end user, that a screw fell out of the rollator, causing her to fall.

• Type of Device: ROLLATOR, STEEL, KNOCK-DOWN
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield, il
• Manufacturer Contact: kathy woods ; three lakes drive; northfield, il ; 9317708
• MDR Report Key: 10044892
• MDR Text Key: 203634018
• Report Number: 1417592-2020-00050
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850ESKD
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/11/2020
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 122