MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-02-05 for CHATTANOOGA ULTRASOUND APPLICATOR, 5 CM, GRAY 27383 manufactured by Djo, Llc.
[182179561]
No device was returned for evaluation. If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Patient Sequence No: 1, Text Type: N, H10
[182179562]
It was reported that "during patient visit e-stim machine used on patient. When patient went home she noticed 4 distinct burn marks on her back where the e-stim pads had been placed. Patient went to urgent care where she was dx with partial thickness burns and silvadene dressing placed along with order to follow up with her pcp (primary care physician) and wound care clinic. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012446970-2020-00003 |
| MDR Report Key | 9670740 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-11-15 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-05 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN BECKER |
| Manufacturer Street | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE TX 75067 |
| Manufacturer Country | US |
| Manufacturer Postal | 75067 |
| Manufacturer G1 | DJO, LLC |
| Manufacturer Street | 3151 SCOTT ST. |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92081 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA ULTRASOUND APPLICATOR, 5 CM, GRAY |
| Generic Name | ULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT |
| Product Code | IMI |
| Date Received | 2020-02-05 |
| Model Number | 27383 |
| Operator | HEALTH PROFESSIONAL |
| 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 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-05 |