MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-10-21 for TRACTION SET CERVICAL OVERDOOR 4390 manufactured by Chattanooga Group.
[15502636]
The patient was prescribed the use of the over the door traction kit by her physical therapist. The kit was purchased. The patient took the kit into her physical therapist and they discussed how the kit should be used. At home, she and her spouse set up the traction kit and per instructions from her physical therapist added 10 pounds of water to the bag. The patient followed instruction placing her chin into the chin strap and place the second strap around the back of her head according to instructions. The patient has worked in the medical profession and indicated that she knew when to stop. The treatment was painful and seemed to her that it was pulling too much on the chin. After about two minutes, the patient stopped using the device due to intense pain. Her physical therapist suggested that she try the device a second time and the same problem occurred, jaw and neck pain. The patient feels that the design of the device pulls up too much on the chin and if the head is held with the eyes straight forward the chin strap cuts into the neck. The device will be returned for evaluation. The patient did not feel that any injury occurred or that her progress was impeded. She strongly felt that the product just does not work properly and that the manufacturer should know.
Patient Sequence No: 1, Text Type: D, B5
[15654178]
The device has been received and is currently under evaluation. The device evaluation and any additional findings will be provided upon conclusion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00296 |
| MDR Report Key | 1205964 |
| Report Source | 04 |
| Date Received | 2008-10-21 |
| Date of Report | 2008-09-30 |
| Date of Event | 2008-09-30 |
| Date Mfgr Received | 2008-09-30 |
| Date Added to Maude | 2008-10-28 |
| 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 | TRACTION SET CERVICAL OVERDOOR |
| Generic Name | MANUAL CERVICAL TRACTION DEVICE |
| Product Code | ILZ |
| Date Received | 2008-10-21 |
| Model Number | 4390 |
| Catalog Number | 4390 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1255100 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-21 |