MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-31 for CHATTANOOGA 2802 manufactured by Djo, Llc.
[25288972]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[25288975]
Complaint received that alleges "customer stated that the unit had "exploded"". 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 | 9616086-2015-00024 |
MDR Report Key | 5042351 |
Date Received | 2015-08-31 |
Date of Report | 2015-08-31 |
Date of Event | 2015-08-24 |
Date Mfgr Received | 2015-08-24 |
Date Added to Maude | 2015-08-31 |
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 |
Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
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 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
Manufacturer City | TIJUANA, MEXICO 22244 |
Manufacturer Country | MX |
Manufacturer Postal Code | 22244 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CHATTANOOGA |
Generic Name | HYDROCOLLATOR |
Product Code | IRQ |
Date Received | 2015-08-31 |
Model Number | 2802 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
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 | 2015-08-31 |