MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-06 for G30757W manufactured by Medline Industries Inc..
[173928179]
It was reported that the customer underwent a right total knee arthroplasty on (b)(6) 2016 and while at the hospital the customer was in the washroom with the guardian walker when the customer experienced an unwitnessed fall which the customer stated is related to the wheel on the walker breaking. The customer is reporting that he fell on the ground and the fall reinjured the surgical and operative site of the right total knee replacement leading to unspecified surgeries, hospitalizations, care, treatments and ongoing therapy. The actual device was not returned to the manufacturer, however the device was allowed to be evaluated at a third party location by the manufacturer and it was determined that the incident that occurred is not representative of the walker being used according to manufacturer recommendations. No additional information is 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
[173928180]
It was reported that after surgery the customer experienced an unwitnessed fall which the customer stated is related to the wheel on the walker breaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00203 |
| MDR Report Key | 9553322 |
| Report Source | OTHER |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2016-12-28 |
| Date Mfgr Received | 2019-07-02 |
| Date Added to Maude | 2020-01-06 |
| 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 | WALKER, GUARDIAN,W/5IN WHEEL,ADULT |
| Product Code | ITJ |
| Date Received | 2020-01-06 |
| Model Number | G30757W |
| Lot Number | 88516090027 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-06 |