MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-04 for DEFLUX 011504 UNK manufactured by Palette Life Sciences.
[177799206]
Deflux is approved for the treatment of children with vesicoureteral reflex (vur) grades ii-iv. This procedure for velopharyngeal insufficiency is an off-label procedure. The labeling for deflux states, "deflux is to be administered only by qualified surgeons experienced in the use of a cystoscope and trained in the technique of subureteric and/or interureteric injections (with deflux or other materials)". This procedure was not subureteric and/or interureteric. In addition, it appears the patient had a preexisting metal pharyngeal implant for sleep apnea jaw surgery, which increases the risk of infection.
Patient Sequence No: 1, Text Type: N, H10
[177799207]
Patient underwent a procedure where the deflux was injected into the patient's soft palette, which is an off-label use of product. The patient had previously undergone plating of her jaw for sleep apnea. The patient presented with an infection of the lower jaw and stated that it may be related to the prior sleep apnea jaw surgery. The patient was treated with antibiotics for the bone infection, removal of the metal plates, and debridement of necrotic bone and tissue. The patient also complained of headaches and numbness in her face. This is the same patient/ event reported in medwatch #9710154-2020-00012.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014909464-2020-00001 |
| MDR Report Key | 9667333 |
| Report Source | CONSUMER |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-03 |
| Date of Event | 2019-01-19 |
| Date Added to Maude | 2020-02-04 |
| 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 | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CLIFF KLINE |
| Manufacturer Street | 27 E. COTA STREET |
| Manufacturer City | SANTA BARBARA CA 93101 |
| Manufacturer Country | US |
| Manufacturer Postal | 93101 |
| Manufacturer Phone | 8058697056 |
| Manufacturer G1 | PALETTE LIFE SCIENCES |
| Manufacturer Street | 27 E. COTA STREET |
| Manufacturer City | SANTA BARBARA CA 93101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEFLUX |
| Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
| Product Code | LNM |
| Date Received | 2020-02-04 |
| Model Number | 011504 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALETTE LIFE SCIENCES |
| Manufacturer Address | 27 E. COTA STREET SANTA BARBARA CA 93101 US 93101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-04 |