MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ROLLATOR,BASIC,STEEL,6",BLUE

Catalog Number MDS86850EBS

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 07/24/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer, on (b)(6) 2022 the "sharp screw protruding on the right rail" cut her leg.The customer reported she required 7 sutures, was prescribed daily antibiotics from a physician, and required follow-up care at a wound clinic.The customer reported the scar was healed by (b)(6) 2023 but, a scar is still present.Sample was requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, 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, on (b)(6) 2022 the "sharp screw protruding on the right rail" cut her leg.

• Type of Device: ROLLATOR,BASIC,STEEL,6",BLUE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17553300
• MDR Text Key: 321221638
• Report Number: 1417592-2023-00340
• 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: 08/15/2023

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: MDS86850EBS
• Device Lot Number: 88517070001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other