MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-03-13 for MDS86222CHR manufactured by Medline Industries Inc..
[102245291]
It was reported by the customer's mother that her son was standing up using his quadcane when the quadcane collapsed down resulting in a fall. Reportedly, the cane button for height adjustment came loose. The customer hit his forehead on the floor resulting in a laceration that required 9 stitches to close. Numerous attempts have been made to contact the customer to obtain additional information related to the incident; however the customer was not available to be able to obtain additional details. The device was not returned for evaluation, therefore a device analysis could not be completed and a root cause could not be determined. Due to the reported incident, this medwatch is being filed. No additional information was provided. Should additional relevant information become available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[102245292]
It was reported that the customer fell while using quadcane sustaining a laceration to forehead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00014 |
| MDR Report Key | 7334495 |
| Report Source | CONSUMER |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-13 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-02-22 |
| Date Added to Maude | 2018-03-13 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CANE, QUAD, SMALL BASE, CHROME |
| Product Code | IPS |
| Date Received | 2018-03-13 |
| Catalog Number | MDS86222CHR |
| 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 | 2018-03-13 |