MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-05-31 for CHATTANOOGA ADP30000212FC manufactured by Djo, Llc.
[46202820]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[46202821]
Complaint received that alleges "the pedal has an issue with raising and lowering. Attempted to lower the head piece. The whole pin piece snapped off. Clinic indicates "one of the patients fell down. As far as we know, they were not hurt". Questionnaire not received from clinician and/or patient. Device not returned to manufacturer for evaluation. No indication event caused or contributed to serious injury, permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020737-2016-00005 |
| MDR Report Key | 5688603 |
| Report Source | USER FACILITY |
| Date Received | 2016-05-31 |
| Date of Report | 2016-05-31 |
| Date of Event | 2016-05-17 |
| Date Mfgr Received | 2016-05-17 |
| Date Added to Maude | 2016-05-31 |
| 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 | 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 | CONTRACT INDUSRIAL TOOLING (CIT) |
| Manufacturer Street | 2351 PRODUCTION COURT |
| Manufacturer City | RICHMOND IN 47374 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47374 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | ADAPTA ADP300 BLK 28 |
| Product Code | ITH |
| Date Received | 2016-05-31 |
| Model Number | ADP30000212FC |
| 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 | 2016-05-31 |