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

Catalog Number MDS86850EG

Device Problems Component Missing (2306); Misassembled During Installation (4049)

Patient Problem No Code Available (3191)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the bolt (for the height adjustment) was not received with the new rollator that was purchased online.When end-user used the rollator for the first time, while end user was walking using the rollator (end user was unaware that bolt was missing), the left handle dropped resulting in end user falling onto her knee.The end user stated that she had x-rays and ultrasound done, which revealed that she tore her meniscus.Per report, end user is currently wearing a knee brace, is following up with an orthopedic specialist and is scheduled to have an mri done.Due to the reported torn meniscus, this medwatch is being filed.Photos of the rollator were submitted and the complaint of a missing left handle height adjustment screw was confirmed.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the new rollator was received with missing bolt (for the height adjustment).When end-user used the rollator for the first time (unaware that bolt was missing), she fell and sustained a meniscus tear.

• Type of Device: ROLLATOR,BASIC,GREEN
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8640054
• MDR Text Key: 146056973
• Report Number: 1417592-2019-00079
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850EG
• Device Lot Number: 88519010003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 82