MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-08-10 for SAUNDERS CERVICAL TRACTION 7040 manufactured by Chattanooga Group.
[22235651]
On (b)(6) 2010, patient reported that she had a herniated disk and went to a rehabilitation clinic and was treated with a saunders cervical. The two bars were on her jaw, not neck, and it affected her jaw. She was in the device for 7 minutes and she stopped it. After the treatment was discontinued, she says that the side of her jaw is now overlapped on the right side, her bite is terrible and her hearing is diminished. In an email on (b)(6) 2010, the patient also stated that she has been diagnosed with "right side jaw dislocation and a closed lock my opening is at 7mm... , buccal trigeminal nerve damage possibly more nerves due to the extent of the numbness in the right side of face and head. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022819-2010-00012 |
| MDR Report Key | 1812319 |
| Report Source | 00 |
| Date Received | 2010-08-10 |
| Date of Report | 2010-07-06 |
| Date of Event | 2010-07-06 |
| Date Mfgr Received | 2010-07-06 |
| Date Added to Maude | 2010-08-26 |
| 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 Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | CHATTANOOGA GROUP |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAUNDERS CERVICAL TRACTION |
| Generic Name | CERVICAL TRACTION CLINICAL |
| Product Code | IRS |
| Date Received | 2010-08-10 |
| Model Number | 7040 |
| Catalog Number | 7040 |
| 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 | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-08-10 |