MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-07-28 for HYDROCOLLATOR TX-1 * manufactured by Chattanooga Group, Inc..
[181165]
During course of treatment, 13 mins into 15 min session, the rope applying steady pull on traction bar suddenly dislodged out of machine, creating a sudden release of all tension and pt sustained a sudden jerk. Rope was noted to have not broken but had somehow unwound in internal mechanism and suddenly released during this treatment session.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019401 |
| MDR Report Key | 288153 |
| Date Received | 2000-07-28 |
| Date of Report | 2000-07-28 |
| Date of Event | 2000-07-21 |
| Date Added to Maude | 2000-08-04 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDROCOLLATOR |
| Generic Name | TX TRACTION UNIT |
| Product Code | ITH |
| Date Received | 2000-07-28 |
| Model Number | TX-1 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | HOSP INVENTORY #: 01720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 278850 |
| Manufacturer | CHATTANOOGA GROUP, INC. |
| Manufacturer Address | 4717 ADAMS RD. HIXSON TN 37343 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-07-28 |