MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-25 for MDS86420 manufactured by Medline Industries Inc..
[186542536]
It was reported by the end user that he slipped and fell while he was ambulating on his recently painted cement porch. The end user stated it was raining outside and due to the wet surface, his cane tip slipped and he fell landing on his tailbone. The end user reported that he was able to get up with assistance of people nearby and was assisted back into the house without further incident. The end user stated that the next day he was in pain and he went to the emergency department for evaluation. The end user stated that x-rays were taken and he was diagnosed with a tailbone fracture. The emergency room physician prescribed the end user percocet and meloxicam for pain and the end user was discharged home the same day without further treatment. No additional information is available. The sample was not returned to the manufacturer for evaluation. A definitive root cause for the reported issue could not be determined at this time. There is no additional information 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
[186542537]
It was reported the end user fell while ambulating with his cane and fractured his tailbone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00018 |
| MDR Report Key | 9751856 |
| Report Source | CONSUMER |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-02-25 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 6434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CANE, OFFSET, BLACK, ALUMINUM, |
| Product Code | IPS |
| Date Received | 2020-02-25 |
| Catalog Number | MDS86420 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-25 |