MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2009-01-02 for NONE manufactured by Chattanooga Group.
[997988]
Following information was provided via letter from health facility: patient 1 of 2: patient was being treated for headache and during treatment, the head of the drop table dropped and patient's head fell back. Patient felt discomfort in back of head and neck. Headrest was raised and treatment was continued. Patient continued to feel discomfort in head and neck and claims to have suffered from posterior circulation ischemic events secondary to vertebral artery dissection as a result of this treatment.
Patient Sequence No: 1, Text Type: D, B5
[8204102]
Information provided by health facility, did not include identification of the device in question or identify that the device was manufactured by chattanooga group.
Patient Sequence No: 1, Text Type: N, H10
[6075966]
Following information was provided via letter from health facility: patient 2 of 2: patient suffered an injury to chest after use of drop chiropractic table. Chiropractic treatments continued for several months and each session began with two or three table drops. Chiropractor indicated that table drops would realign parts of his body. Over time, patient experienced chest pain which were diagnosed as costochondral separation with perichondrial new cartilage formation. As result of treatment, patient indicated is in constant pain and require surgery.
Patient Sequence No: 2, Text Type: D, B5
[13518711]
Information provided by health facility, did not include identification of the device in question or confirmation that device was manufactured by chattanooga group.
Patient Sequence No: 2, Text Type: N, H10
| Report Number | 1022819-2008-00358 |
| MDR Report Key | 1280489 |
| Report Source | 00,01 |
| Date Received | 2009-01-02 |
| Date of Report | 2006-07-14 |
| Date Added to Maude | 2009-01-12 |
| 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 | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238707207 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | INQ |
| Date Received | 2009-01-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | 4717 ADAMS RD. HIXSON TN 37343 US 37343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-01-02 |
| 2 | 0 | 1. Other | 2009-01-02 |