MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-10-03 for 6020F CHAIR manufactured by Clinton Industries.
[16753298]
As described to clinton industries by email from (b)(6), end-user facility, (b)(6): after completing a blood draw for research purposes and still seated in the chair with the arm rest across his body, the research participant fainted and fell forward. As he was falling to the floor the chair was tipping with him. The individual sustained significant facial injuries related to the fall. As described to clinton industries by email from (b)(6), (distributor of device involved) during a taped telephone interview of "(b)(6)" (last name inaudible) from (b)(6): patient passed-out after the puncture in the arm, arm of the chair was down, they hunched down and the whole chair flipped forward. They fell onto the ground causing significant injuries.
Patient Sequence No: 1, Text Type: D, B5
[16997704]
Pictures of the chair in question where included from the end user and did not show any defects or failures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3001452523-2012-00001 |
| MDR Report Key | 2774294 |
| Report Source | 08 |
| Date Received | 2012-10-03 |
| Date of Report | 2012-09-27 |
| Date of Event | 2012-09-10 |
| Date Mfgr Received | 2012-09-17 |
| Device Manufacturer Date | 2011-07-11 |
| Date Added to Maude | 2012-10-09 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1140 EDISON ST. |
| Manufacturer City | YORK PA 17403 |
| Manufacturer Country | US |
| Manufacturer Postal | 17403 |
| Manufacturer Phone | 7178483519 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6020F CHAIR |
| Generic Name | BLOOD DRAWING CHAIR |
| Product Code | FML |
| Date Received | 2012-10-03 |
| Model Number | 6020F |
| Catalog Number | 6020F |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINTON INDUSTRIES |
| Manufacturer Address | YORK PA 17403 US 17403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-03 |