MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-09-25 for UNK manufactured by Medline Industries Inc..
[121646779]
It was reported that the customer was using a four point cane and the cane snapped in half resulting in the customer requiring spinal fusion surgery and subsequently being admitted to an assisted living facility. The customer's husband reported the incident to the fda; however did not report the incident to the manufacturer because he did not know the name of the actual manufacturer. No product code or lot number is available. The reporter stated that he was not in the room when his wife fell so he is not able to provide any additional details related to this report and abruptly ended the call. The actual sample is not available to be returned for evaluation due to the actual sample involved in the incident being thrown away. No additional information is available. Due to the reported incident, reported surgical intervention and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[121646780]
It was reported that the cane broke during use and the customer fell.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00101 |
| MDR Report Key | 7907329 |
| Report Source | CONSUMER |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-09-25 |
| Date Added to Maude | 2018-09-25 |
| 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 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 | CANE |
| Product Code | IPS |
| Date Received | 2018-09-25 |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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. Required No Informationntervention | 2018-09-25 |