MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-01 for MDS808150E manufactured by Medline Industries, Inc..
[39423644]
The end user's daughter reported that her father fell backwards while leaning back in the chair and hit his legs under a table. It is unknown if the brakes were engaged. He was diagnosed with cellulitis on his legs due to redness and swelling and was treated with an antibiotic. It is unknown if his skin integrity was compromised. The sample was not returned for evaluation and a root cause has not been determined. The owner's manual addresses center of gravity, balance and stability. It indicates that the center of gravity must be maintained and that the loss of proper balance may cause the transport chair to tip over. We cannot rule out user error as a potential root cause. Due to the need for medical intervention and in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[39423685]
The end user's daughter reported that her father fell backwards while leaning back in the chair and hit his legs under a table.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00017 |
| MDR Report Key | 5471790 |
| Date Received | 2016-03-01 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-02-05 |
| Date Mfgr Received | 2016-02-09 |
| Date Added to Maude | 2016-03-01 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 0 |
| Generic Name | TRANSPORT CHAIR |
| Product Code | INM |
| Date Received | 2016-03-01 |
| Catalog Number | MDS808150E |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| 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 | 2016-03-01 |