MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-07-25 for MDS808200TRR manufactured by Medline Industries, Inc..
[50314744]
It was reported that the end user got out of a car and was ambulating on pavement. She attempted to turn right and apparently the device did not respond. She lost her footing and fell to her left side, suffering a fractured hip. She was admitted to the hospital. It is not known what treatment, if any, was initiated. The incident and subsequent fall was not witnessed. No lot number was provided. We have no sample or photos to evaluate. We have minimal information regarding what actually transpired. It is not known what role the device played in the reported incident. A root cause has not been determined. However, in an abundance of caution, due to the reported incident and subsequent injury, this medwatch is being filed. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[50314765]
The end user fell while ambulating with the device and fractured her hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00075 |
| MDR Report Key | 5818799 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-07-25 |
| Date of Report | 2016-07-25 |
| Date of Event | 2016-06-24 |
| Date Mfgr Received | 2016-06-27 |
| Date Added to Maude | 2016-07-25 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 |
| Generic Name | TRANSLATOR, ROLLLATOR/TRANSPORT CHAIR |
| Product Code | INM |
| Date Received | 2016-07-25 |
| Catalog Number | MDS808200TRR |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2016-07-25 |