MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-05 for MDS808200F3B manufactured by Medline Industries Inc..
[177931759]
It was reported by the medical supply company that the end user experienced a fall. According to the end user's daughter that that during a daily dressing change she was performing to her father's left leg for edema she lifted up his left leg and the transport chair tipped backwards, resulting in her father falling backwards and hitting his head on the ground. The end user's daughter reported that eh paramedics were called and the end user was transported to the hospital where he received 5 staples to the back of his head for a cut that he sustained during the fall. The end user's daughter reported that the end user was treated and released the same day without further incident. The device was returned for evaluation and was found to have both push handles fractured at the welds possibly due to the impact from the fall. 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
[177931760]
It was reported that the end user was sitting in the chair when the chair flipped backwards and the end user fell to the ground hitting his head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00002 |
| MDR Report Key | 9673463 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-02-05 |
| 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 | WHEELCHAIR,TRANSPORT,ULTRALGHT 3,BLUE |
| Product Code | INM |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-01-15 |
| Catalog Number | MDS808200F3B |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-05 |