MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-03 for MDS89745R manufactured by Medline Industries Inc..
[96331102]
It was reported that while using the shower chair, on (b)(6) 2017, the end user fell and suffered a subdural hematoma. The sample was not returned for evaluation. No additional information was provided related to the reported incident. The condition of the device is not known. A root cause has not been determined. It is not known if the device caused or contributed to the fall. No additional information is available. A sample has not been returned for evaluation however, due to the reported incident and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[96331103]
End user fell while using the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00001 |
| MDR Report Key | 7161987 |
| Date Received | 2018-01-03 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-04-12 |
| Date Mfgr Received | 2018-01-02 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2018-01-03 |
| 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 |
| 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 | 0 |
| Generic Name | BENCH,BATH,W/ BACK |
| Product Code | IKX |
| Date Received | 2018-01-03 |
| Catalog Number | MDS89745R |
| Lot Number | E101253714 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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. Other | 2018-01-03 |