MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-06-01 for CHATTANOOGA 42198 manufactured by Djo, Llc.
[76449943]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[76450044]
Complaint received that alleges "allergy all over the body except feet and hands/ burn skin almost stuck on electrode. Electrodes used with device tens eco 2 (competitor =schwa-medico)-the patient came to hospital to consult a dermatologist". Questionnaire not received from customer or clinician. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[92986310]
Product was returned for review. "there was evidence of foreign material that appears to be dirt and other contaminants. In addition, mold appears to be present, which can be caused when an electrode is worn during periods of heavy sweating and/or stored improperly. While many steps are taken to prevent skin irritation, a small percentage of customers are allergic or sensitive to hydrogel formulations".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2017-00010 |
| MDR Report Key | 6605801 |
| Report Source | FOREIGN |
| Date Received | 2017-06-01 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-05-17 |
| Date Mfgr Received | 2017-06-23 |
| Date Added to Maude | 2017-06-01 |
| 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 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, 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 | LABELED DURA-STICK+ 5CM SQUARE 4/PK |
| Product Code | GXY |
| Date Received | 2017-06-01 |
| Model Number | 42198 |
| Operator | LAY USER/PATIENT |
| 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 | 1. Other | 2017-06-01 |