MDS86850ESKD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-07 for MDS86850ESKD manufactured by Medline Industries Inc..

Event Text Entries

[186542028] It was reported that while using a rollator, the device broke and the end user fell. The end user reported that he was walking on concrete with the rollator and the right rear wheel broke in 2 resulting in him falling backwards. The end user stated that the cab driver helped him up and helped him into the cab to get him back to his house. The end user reported that he did not go to the doctor or hospital after the event occurred. The end user stated that the fall happened on (b)(6) 2019 and 3-4 days later he went to a follow up appointment with a doctor that he had been seeing for a leg injury that he sustained 2 years prior for an unrelated incident. Reportedly, the doctor took x-rays of the previous leg injury to see if there was a disruption of the previous injury and found there was no disruption of the previous injury and no fracture noted. The end user reported that the doctor did not evaluate the end user for any back injury or back pain. The end user stated that after an unreported number of days he started feeling back pain, went through the yellow pages of the phone book and found a different doctor that he went to for evaluation of back pain that he was having. The end user reported that he went to the doctor for evaluation and after having x-rays and an mri the doctor told the end user that he has an unspecified fracture in his back. Reportedly, no additional information related to the fracture was reported to the patient, but he thinks it is from the fall. No additional information is available. The device was not returned to the manufacturer for evaluation. The customer reported issue was not confirmed. No additional information is available. Due to the reported incident, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[186542029] Reportedly per the end user, the back wheel of the rollator broke causing him to fall and fracture his back.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417592-2020-00009
MDR Report Key9683332
Report SourceCONSUMER
Date Received2020-02-07
Date of Report2020-02-07
Date of Event2019-10-26
Date Mfgr Received2020-01-08
Date Added to Maude2020-02-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKAREN TRUTSCH
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 60093
Manufacturer CountryUS
Manufacturer Postal60093
Manufacturer Phone8476434960
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameROLLATOR, STEEL, KNOCK-DOWN
Product CodeITJ
Date Received2020-02-07
Catalog NumberMDS86850ESKD
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.