MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-08-02 for QUAD CANE TIP MDS86424W manufactured by Medline Industries, Inc..
[4689361]
The cane tip wore through and the end user fell.
Patient Sequence No: 1, Text Type: D, B5
[12309224]
While walking at home, the end user reported that she fell when the cane tip wore through. She suffered a bruise to her face and knee and fractured her right hand. The fracture was treated with a brace. She was hospitalized for two days for observation and was discharged home with physical therapy. No lot number was provided and the sample was not returned for evaluation. No photos were sent. The product number for the cane was not reported. She stated it is a quad cane. The condition of the other three tips is not known. In the absence of a sample, a root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00075 |
| MDR Report Key | 4006562 |
| Report Source | 04 |
| Date Received | 2014-08-02 |
| Date of Report | 2014-07-29 |
| Date of Event | 2014-06-24 |
| Date Mfgr Received | 2014-06-30 |
| Date Added to Maude | 2014-08-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUAD CANE TIP |
| Product Code | INP |
| Date Received | 2014-08-02 |
| Catalog Number | MDS86424W |
| Lot Number | UNK |
| 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 | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2014-08-02 |