MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ROLLATOR

Catalog Number MDS86825DLX3

Device Problem Entrapment of Device (1212)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported that the end user caught her finger in the handle of the rollator, resulting in a skin tear.

Manufacturer Narrative

The end user's daughter reported that her mother caught her finger in the handle of the rollator resulting in a large skin tear.Cauterization was required to stop the bleeding.The sample has not been returned for evaluation.We have no information to suggest a manufacturing defect was present.A root cause has not been determined.

• Brand Name: ROLLATOR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4906148
• MDR Text Key: 19610778
• Report Number: 1417592-2015-00057
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 07/01/2015

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: MDS86825DLX3
• Device Lot Number: 86715010003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other