MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-29 for CHATTANOOGA ADP100 manufactured by Djo, Llc.
[35100698]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[35100699]
Complaint received that alleges "as i went to lower the table there was a small pop. The table dropped/collapsed straight down stopping when it reached the bottom or lower position, patient insisted she was okay". Questionnaire was not received from clinician and/or patient. Device not returned to manufacturer for evaluation. No indication event caused or contributed to permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020737-2015-00006 |
| MDR Report Key | 5332039 |
| Date Received | 2015-12-29 |
| Date of Report | 2015-12-29 |
| Date of Event | 2015-12-15 |
| Date Added to Maude | 2015-12-29 |
| 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 | MEDICAL ASSISTANT |
| 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 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607313126 |
| Manufacturer G1 | DJO, LLC |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 920819663 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CHATTANOOGA |
| Generic Name | ADAPTA TABLE |
| Product Code | LWG |
| Date Received | 2015-12-29 |
| Model Number | ADP100 |
| Operator | MEDICAL ASSISTANT |
| 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 | 2015-12-29 |