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 2018-09-24 for EXOS 310-41-1111 manufactured by Djo, Llc.
[121558225]
It was reported that the patient experienced burns and red patches after 10 days of wearing the device. The splint was removed on the advice of the pharmacy and the patient received care at the hospital with prescription of flammazine and tulle gras. The patient's general practitioner diagnosed an allergic reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2018-00022 |
| MDR Report Key | 7903084 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-09-24 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-08-18 |
| Date Mfgr Received | 2018-10-16 |
| Date Added to Maude | 2018-09-24 |
| 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 | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| 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 | EXOS |
| Generic Name | ORTHOSIS, LIMB BRACE |
| Product Code | IQI |
| Date Received | 2018-09-24 |
| Model Number | 310-41-1111 |
| Lot Number | 022118/180122 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-09-24 |