MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,GUARDIAN,DELUXE,ALUMINUM,ROSE

Catalog Number G07887R

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the end-user experienced tendonitis from the repetitive lifting of the folded rollator into her car with one hand.Reportedly, when folded, an unidentified piece of the device "digs" into her right palm and she experienced tendonitis to her right hand.The end-user states she began to use her left arm to lift the folded rollator after experiencing tendonitis to her right hand and she then experienced tendonitis to her left elbow.According to the end-user she has required physical therapy for her tendonitis as well as an unidentified "shot" as treatment.No diagnostic exams were reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause could not be determined.Due to the need for medical intervention this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the end-user experienced tendonitis and required medical intervention.

• Type of Device: ROLLATOR,GUARDIAN,DELUXE,ALUMINUM,ROSE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7901582
• MDR Text Key: 121457316
• Report Number: 1417592-2018-00100
• 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
• Type of Report: Initial
• Report Date: 09/24/2018

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: G07887R
• Device Lot Number: 86717120007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 101