MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; DBD-ROLLATOR,WIDE,7" WHEELS

Catalog Number MDS86835C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 02/01/2018

Event Type  Death  

Manufacturer Narrative

It was reported by the customer's wife that the customer fell while ambulating with a rollator.The customer experienced "soreness," bruising," and a "gash" to his left leg.The wife reported that paramedics were called after the fall and provided wound care on site but the customer did not go to the local hospital for evaluation.The wife did not report a specific date of incident but noted it occurred (b)(6) 2018.According to the wife, three days after the fall, the customer's "gash" continued to bleed and paramedics were called at that time to take the customer to the local hospital where an evaluation was completed.The diagnostics and treatments performed during this evaluation were not reported.After the evaluation, the customer was admitted to the hospital.The admitting diagnosis was not reported.Per the wife, the customer died approximately one week after admission.The cause of death was not reported.The date of death was not reported.Although specific diagnoses were not provided, the wife reported that the customer had a complex medical history and that he was chronically taking "blood- thinners" at the time the fall occurred.The sample was discarded and was not available to be returned to the manufacturer for evaluation.Due to the need for initial hospitalization and reported customer death this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported by the customer's wife that the customer fell while ambulating with a rollator.Reportedly, one week after admission to the hospital the customer died.

• Type of Device: DBD-ROLLATOR,WIDE,7" WHEELS
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093 ; 2249311458
• MDR Report Key: 7309858
• MDR Text Key: 101388420
• Report Number: 1417592-2018-00013
• 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: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86835C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 84 YR