MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-05-09 for CHATTANOOGA TXE-1 2562 * manufactured by The Chattanooga Group Inc.
[18335192]
Pt here for treatment of back pain. Place on traction unit table. Traction pressure manually progressed to 120 lbs over 3 steps. Just as reaching targer of 120 lbs, tautness in cable/rope suddenly gave out, went slack, causing pt to jerk and report increase in back pain and muscle spasms. Pt treated and released from emergency dept. Pt now alleging "serious personal injuries". Unable to confirm the nature of these.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 331537 |
| MDR Report Key | 331537 |
| Date Received | 2001-05-09 |
| Date of Report | 2001-05-09 |
| Date of Event | 2001-04-30 |
| Date Facility Aware | 2001-04-30 |
| Report Date | 2001-05-09 |
| Date Reported to Mfgr | 2001-05-09 |
| Date Added to Maude | 2001-05-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | TRACTION (UNIT) TABLE |
| Product Code | JFB |
| Date Received | 2001-05-09 |
| Model Number | TXE-1 2562 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 16 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 320903 |
| Manufacturer | THE CHATTANOOGA GROUP INC |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-09 |