MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-03 for CHATTANOOGA APPLICATOR 13CLS 3X200MW 715MW 27816 manufactured by Djo, Llc.
[182180741]
Initial reporter information: unknown. 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
[182180742]
It was reported that the "output is hot and causing customer to pull away from treatment. " there was no reported patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012446970-2020-00002 |
| MDR Report Key | 9659421 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-02 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2010-04-30 |
| Date Added to Maude | 2020-02-03 |
| 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 | 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 APPLICATOR 13CLS 3X200MW 715MW |
| Generic Name | LAMP, INFRARED, THERAPEUTIC HEATING |
| Product Code | ILY |
| Date Received | 2020-02-03 |
| Model Number | 27816 |
| 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 | 2020-02-03 |