MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-11 for HYLO TABLE 9510 manufactured by Chattanooga Group.
[2603196]
The table head piece elevation adjustment function would not secure the head piece elevation from movement. No pt involvement or injury.
Patient Sequence No: 1, Text Type: D, B5
[9956898]
The device has been returned. The device will be evaluated. The eval findings will be reported via the form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2009-00080 |
| MDR Report Key | 2543833 |
| Report Source | 05 |
| Date Received | 2009-03-11 |
| Date of Report | 2009-02-10 |
| Date Mfgr Received | 2009-02-10 |
| Date Added to Maude | 2012-04-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYLO TABLE |
| Product Code | INQ |
| Date Received | 2009-03-11 |
| Returned To Mfg | 2009-03-03 |
| Model Number | 9510 |
| Catalog Number | 9510 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-11 |