MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-11-03 for WRX449723 manufactured by Medline Industries Inc.
[59037677]
This is a report from the end user's wife who stated her husband got out of the car with his cane and she took the transport chair out of the car. She locked the transport chair and stood on the side of the chair while her husband sat down in the chair unassisted. Upon sitting down in the transport chair the chair fell back causing the customer to hit his head on the cement ground in the parking lot. The customer was taken to the hospital where he had a ct scan performed showing that he had a brain bleed. The customer was admitted to the icu for six days and then transported to a skilled nursing facility for rehab. The customer has a medical history of hypertension and was on blood pressure medication as well as blood thinners prior to the fall. Follow up information was obtained from the customer's wife on (b)(6) 2016. Per the customer's wife, her husband has made a drastic improvement (specific details of improvement not specified) since she first reported the fall. The wife stated that the bleeding in the customer's brain has stopped and his physician has restarted the blood thinners that the customer is on for cardiac issues. The customer is still in the skilled nursing facility for physical therapy, but was reportedly doing 25% better this week then last week as he strengthens himself with physical therapy. A root cause has not been determined and we cannot rule out the possibility that the seatback fold-down was not locked in the upright position of the chair. Those who do not have sufficient balance and agility should not transfer in and out of the chair on their own per manufacturer instructions. The customer's wife confirmed that the chair was not properly supported in the back during patient seating per manufacturer instructions. We have not identified a manufacturing defect to be a cause or contributing factor. However, due to the reported incident and subsequent need for medical intervention, this medwatch is being filed. No additional information was provided. Should additional relevant information become available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[59037678]
Customer sat in transport chair and fell backwards hitting his head on the pavement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00113 |
| MDR Report Key | 6075445 |
| Report Source | CONSUMER |
| Date Received | 2016-11-03 |
| Date of Report | 2016-10-28 |
| Date of Event | 2016-09-28 |
| Date Mfgr Received | 2016-10-18 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2016-11-03 |
| 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 | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434960 |
| Manufacturer G1 | MEDLINE INDUSTRIES INC |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | WHEELCHAIR, TRANSPORT |
| Product Code | INM |
| Date Received | 2016-11-03 |
| Returned To Mfg | 2016-10-26 |
| Catalog Number | WRX449723 |
| Lot Number | 73615010011 |
| 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 | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-11-03 |