MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-07 for CMF manufactured by Djo Global.
[2361666]
Neck surgery (b)(4) 2011. Prescribed a growth stimulator late (b)(4) 2011. Late (b)(4) the lymph nodes in my neck swelled up where the neck surgery was done and the surgeon referred me to my to primary care. In turn i was referred to a specialist who diagnosed lymphoma in my neck, (b)(4) 2011. Dates of use: (b)(4) 2011. Event abated after use stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023029 |
| MDR Report Key | 2334876 |
| Date Received | 2011-11-07 |
| Date of Report | 2011-11-07 |
| Date of Event | 2011-08-10 |
| Date Added to Maude | 2011-11-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CMF |
| Generic Name | STIMULATOR |
| Product Code | LOE |
| Date Received | 2011-11-07 |
| ID Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO GLOBAL |
| Manufacturer Address | 599 CARDIGAN ROAD ST. PAUL MN 55126 US 55126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2011-11-07 |