MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-06-18 for DONJOY 11-0659-3-06060 manufactured by Djo, Llc.
[5875648]
Complaint received from customer that alleges "anaphylactic shock and infected sores following wearing the lateral j brace. I have two of the.... I was seen for treatment and given cipro capsules, rocephin 1000mg injection, and bactroban ointment". Questionaire was not received from clinician and/or pt. Device not returned to mfr for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2015-00014 |
| MDR Report Key | 4858602 |
| Report Source | 04 |
| Date Received | 2015-06-18 |
| Date of Report | 2015-06-18 |
| Date of Event | 2015-05-13 |
| Date Added to Maude | 2015-06-23 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION ST. |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | 20230 SUBMETROPOLI EL FLORIDO CARRETERA LIBRE TIJUANA TECATE |
| 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 | DONJOY |
| Generic Name | DRYTEX, LAT PAT KNEE, RT, M, BLK |
| Product Code | LSB |
| Date Received | 2015-06-18 |
| Model Number | 11-0659-3-06060 |
| 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 ST. VISTA, CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-18 |