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..
[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
| Report Number | 1417592-2020-00009 |
| MDR Report Key | 9683332 |
| Report Source | CONSUMER |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2019-10-26 |
| Date Mfgr Received | 2020-01-08 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ROLLATOR, STEEL, KNOCK-DOWN |
| Product Code | ITJ |
| Date Received | 2020-02-07 |
| Catalog Number | MDS86850ESKD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-07 |