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

Catalog Number MDS86850ESKD

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Post Traumatic Wound Infection (2447)

Event Date 09/21/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that while end-user was walking across a parking lot, the rollator's front wheel hit a pothole resulting in end-user accidentally hitting her medial (inside part of) left lower leg onto the l-shape metal on the brakes of the rollator's back wheel.It was denied that end-user fell.The end-user reportedly sustained an approximately 2 ½ by 2 ½ inches wound that developed uncontrolled bleeding.Of note, it was denied that the l-shape metal had any sharp surface.The end-user was reportedly taken to an emergency department, the wound was irrigated with saline, skin flap was "glued," and gauze dressing was applied over the wound.The end-user was reportedly discharged home with prescription for oral antibiotics (keflex).Two days later, the wound reportedly had persistent bleeding and worsening redness.The end-user sought further evaluation and treatment at another hospital where she was admitted for five days for intravenous antibiotics.Reportedly, the end-user was then discharged and now follows-up with a wound care specialist.Due to the reported medical interventions, hospitalization, and need for follow-up care, this medwatch is being filed.The sample has not been returned for evaluation.A definitive root cause could not be determined at this time.There was no report of a failure of the design or manufacturing of the rollator involved in this incident.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the rollator's front wheel hit a pothole resulting in end-user accidentally hitting her left lower leg onto the l-shape metal on the brakes of the rollator's back wheel.The end-user reportedly required hospitalization, antibiotics, and follow-up with wound care specialist.

Manufacturer Narrative

The sample was returned for evaluation.Updated to reflect device being returned.Visual and functional testing was performed.The customer reported issue was not confirmed and the root cause of the customer reported issue was not determined.No additional information is available.If additional relevant information becomes available a supplemental medwatch will be filed.

• Type of Device: ROLLATOR, STEEL, KNOCK-DOWN
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9214120
• MDR Text Key: 170109215
• Report Number: 1417592-2019-00166
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

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: MDS86850ESKD
• Device Lot Number: 05417050003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 100