MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-10-01 for SPINALATOR ERGOSTYLE STATIONARY 8920 manufactured by Chattanooga Group, Inc..
[102311]
Pt seated on chiropractic table turned to lay face down on table. While bracing to lay down, she wrapped her hands around cushion and proceeded to lay down. This section (thoracic) of the table was in the cocked position, but should not have been. The pt's body weight caused the cocked section to release and drop approx 5/8". Pt's right middle finger became caught between plastic stop and bottom of cushion and cut off the tip of her finger (approx 1/4 of pt's nail). The portion of finger was surgically reattached.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022819-1997-00001 |
| MDR Report Key | 124594 |
| Report Source | 05 |
| Date Received | 1997-10-01 |
| Date of Report | 1997-09-29 |
| Date of Event | 1997-09-04 |
| Date Mfgr Received | 1997-09-08 |
| Device Manufacturer Date | 1997-08-01 |
| Date Added to Maude | 1997-10-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINALATOR ERGOSTYLE STATIONARY |
| Generic Name | CHIROPRACTIC TABLE |
| Product Code | JFB |
| Date Received | 1997-10-01 |
| Model Number | 8920 |
| Catalog Number | 8920 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 121981 |
| Manufacturer | CHATTANOOGA GROUP, INC. |
| Manufacturer Address | 4717 ADAMS RD. PO BOX 489 HIXSON TN 37343 US |
| Baseline Brand Name | SPINALATOR ERGOSTYLE STATIONARY |
| Baseline Generic Name | CHIROPRACTIC TABLE |
| Baseline Model No | 8920 |
| Baseline Catalog No | 8920 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-10-01 |