MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ROLLATOR, DELUXE COMFORT, 300 LBS

Catalog Number MDS86826SC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 08/26/2022

Event Type  Injury  

Event Description

According to the customer on (b)(6) 2022 he was sitting stationary outside on his rollator device when the front right wheel fell of and the customer fell to the ground.Per the customer he experienced worsening pain after the fall and after, 'a few days went to the local hospital and received narcotic pain medication and steroids to reduce inflammation'.

Manufacturer Narrative

According to the customer on (b)(6) 2022 he was sitting stationary outside on his rollator device when the front right wheel fell off and the customer fell to the ground.Per the customer he experienced worsening pain after the fall and after, 'a few days went to the local hospital and received narcotic pain medication and steroids to reduce inflammation'.Per the customer he is doing better and was discharged from the emergency room 30 minutes after receiving the medication.The device is available but has not been returned for evaluation.No additional information is available at this time.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, DELUXE COMFORT, 300 LBS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15495081
• MDR Text Key: 300702400
• Report Number: 1417592-2022-00181
• 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
• Report Date: 09/27/2022

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: MDS86826SC
• Device Lot Number: 88521110001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 109 KG