MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for CHATTANOOGA ADP30000212FC manufactured by Djo, Llc.
[106701445]
Complaint received that alleges "the table slipped slightly 1-2 inches and the table abruptly fell from an elevated position to the lowest possible height aprrox. 10 inches, jarring the patient. He immediately c/o mid back pain. He was assisted by the therapist to a seated position and was then assisted w/cg by the therapist to a chair. He was given an ice pack to the mid back and c/o cervical pain and the headache to the l temporal region. 911 was called and his wife. An ice pack was also applied to hi cervical spine. Ems arrived and applied a cervical collar. He was able to transfer with cg assistance by two ems workers to the transport table". Device not received manufacturer at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2018-00009 |
| MDR Report Key | 7466368 |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-03-20 |
| Date Mfgr Received | 2018-04-19 |
| Date Added to Maude | 2018-04-26 |
| 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 |
| Reporter Occupation | PHYSICAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM FISHER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CHATTANOOGA |
| Generic Name | ADAPTA ADP300 BLK 28 |
| Product Code | INQ |
| Date Received | 2018-04-26 |
| Model Number | ADP30000212FC |
| Operator | PHYSICAL THERAPIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-26 |