MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROLLATOR, EMPOWER, BLACK

Catalog Number MDS86845BLKM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, she was walking to the bathroom with the rollator when she "tripped and slid to the floor".The customer reported she cut herself from in "three places under the knee to the ankle" on a "yellow triangular piece" and required a trip to the emergency room.The customer reported the emergency room cleaned her wound, placed "steri-strips", and discharged her home.The customer reported wound care nurses have been coming "three times a week" to apply "medahoney" and bandage the wound.According to the customer, two of the wounds are "healed" and the other is "improving".No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, she was walking to the bathroom with the rollator when she "tripped and slid to the floor".

• Type of Device: ROLLATOR, EMPOWER, BLACK
• 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: 17217580
• MDR Text Key: 318025895
• Report Number: 1417592-2023-00268
• 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: 06/28/2023

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: MDS86845BLKM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/28/2023
• 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): Other