MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-09-30 for CHATTANOOGA 2738 manufactured by Djo, Llc.
[27172977]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[27172978]
Complaint received that alleges "they were doing an e-stim treatment and the unit's intensity continued to increase without anyone turning it up. This caused pain in the resident and when they tried to turn it off, they couldn't and had to pull off the electrodes which then shocked the therapist. The resident has experience constant pain throughout the weekend where the pads were attached. The patient is going to see their primary dr. For these injuries". 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. No indication device caused or contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
[46791735]
Product was returned for review. The product met specifications and did not malfunction. The unit and applicator passed all functional and cosmetic testing. No accessories were included for evaluation (leadwires, electrodes). Additional information does not change original not reportable decision.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2015-00026 |
| MDR Report Key | 5114211 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-09-30 |
| Date of Report | 2016-06-08 |
| Date of Event | 2015-09-21 |
| Date Added to Maude | 2015-09-30 |
| 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 | SERVICE PERSONNEL |
| 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 | INTELECT TRANSPORT COMBO PKG US STD |
| Product Code | IPF |
| Date Received | 2015-09-30 |
| Model Number | 2738 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Other | 2015-09-30 |