MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-04-05 for MDS808200SLBR manufactured by Medline Industries, Inc..
[41895170]
The end user was being pushed in the chair outside and the chair hit a crack in a parking lot. One of the handles on the chair broke. The end user's daughter reported that her mother fell suffering 3 fractured fingers and a minor cut on her forehead. The sample has not been returned for evaluation and photos were not provided. Care, maintenance and overall condition of the chair is unknown. It is unknown if the seat belt was being used. It states in the user's manual that the use of the seat belt is recommended. A root cause has not been determined. However, due to the reported injury, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[41895171]
The end user was being pushed in the chair outside and the chair hit a crack in a parking lot. One of the handles on the chair broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00031 |
| MDR Report Key | 5547901 |
| Report Source | CONSUMER |
| Date Received | 2016-04-05 |
| Date of Report | 2016-04-05 |
| Date of Event | 2016-02-28 |
| Date Mfgr Received | 2016-03-08 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2016-04-05 |
| 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 | DIANE CHRISTENSEN |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TRANSPORT CHAIR |
| Product Code | INM |
| Date Received | 2016-04-05 |
| Catalog Number | MDS808200SLBR |
| Lot Number | U140707281 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2016-04-05 |