MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-03 for MDS86825SLBLK manufactured by Medline Industries Inc..
[173710622]
It was reported that while ambulating, the octagon handle of the rollator with an adjustable screw became loose and the end-user experienced a fall onto a sidewalk. The end-user scraped his right arm during the incident. He was assisted back up and saw his physician and a bandage was placed on the scrape. The end-user experienced pain throughout the night and the day after the incident, went to a local hospital's emergency department (ed) for evaluation. An unspecified x-ray was performed and the end-user was diagnosed with a right sided rib fracture and an unspecified shoulder injury. The end-user will reportedly require follow-up with an orthopedist. A sample was not returned to the manufacturer for evaluation. A root cause for the reported incident was unable to be determined. Due to the reported right sided rib fracture and need for follow-up care, 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
[173710623]
It was reported that the end-user experienced a fall while ambulating with the rollator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00234 |
| MDR Report Key | 9547052 |
| Report Source | CONSUMER |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2019-12-05 |
| Date Added to Maude | 2020-01-03 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ROLLATOR, SUPERLIGHT, BLACK |
| Product Code | ITJ |
| Date Received | 2020-01-03 |
| Catalog Number | MDS86825SLBLK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2020-01-03 |