MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-16 for KYBELLA SKIN GRID manufactured by Allergan (irvine).
[114015303]
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The reporter has declined to provide allergan further information regarding event, product, or patient details. Device labeling: kybella? Is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Limitation of use: the safe and effective use of kybella? For the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. 2. 3 injection technique the safe and effective use of kybella? Depends on the use of the correct number and locations for injections, proper needle placement, and administration techniques. Healthcare professionals administering kybella? Must understand the relevant submental anatomy and associated neuromuscular structures in the area involved and any alterations to the anatomy due to prior surgical or aesthetic procedures. Avoid injections near the area of the marginal mandibular nerve [see warnings and precautions (5. 1)] needle placement with respect to the mandible is very important as it reduces the potential for injury to the marginal mandibular nerve, a motor branch of the facial nerve. Injury to the nerve presents as an asymmetrical smile due to paresis of lip depressor muscles]. To avoid injury to the marginal mandibular nerve:? Do not inject above the inferior border of the mandible. ? Do not inject within a region defined by a 1-1. 5 cm line below the inferior border (from the angle of the mandible to the mentum). ? Inject kybella? Only within the target submental fat treatment area. Do not inject kybella? Outside the defined parameters. ? Using a large bore needle, draw 1 ml of kybella? Into a sterile 1 ml syringe and expel any air bubbles in the syringe barrel. ? Have the patient tense the platysma. Pinch the submental fat and, using a 30 gauge (or smaller) 0. 5 inch needle, inject 0. 2 ml of kybella? Into the pre-platysmal fat (see figure 2) next to each of the marked injection sites by advancing the needle perpendicular to the skin. ? Injections that are too superficial (into the dermis) may result in skin ulceration and necrosis. Do not withdraw the needle from the subcutaneous fat during injection as this could increase the risk of intradermal exposure and potential skin ulceration and necrosis. ? Avoid injecting into the post-platysmal fat by injecting kybella? Into fat tissue at the depth of approximately mid-way into the subcutaneous fat layer (figure 2). ? If at any time resistance is met as the needle is inserted, indicating the possibility of contact with fascial or nonfat tissue, the needle must be withdrawn to an appropriate depth before the injection is administered. ? Avoid injecting into other tissues such as the muscle, salivary glands and lymph nodes. ? Upon needle withdrawal, pressure may be applied to each injection site as necessary to minimize bleeding; an adhesive dressing may be applied.
Patient Sequence No: 1, Text Type: N, H10
[114015304]
Healthcare professional reported "kybella? Was injected into the jowl area off label. " it is unknown if the kybella? Skin grid was used. No additional information was provided. The physician has refused to be contacted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024601-2018-00009 |
| MDR Report Key | 7689414 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-16 |
| Date of Report | 2018-07-16 |
| Date of Event | 2018-06-03 |
| Date Mfgr Received | 2018-06-19 |
| Date Added to Maude | 2018-07-16 |
| 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 | MS. SUZANNE WOJCIK |
| Manufacturer Street | 301 W HOWARD LANE SUITE 100 |
| Manufacturer City | AUSTIN TX 78753 |
| Manufacturer Country | US |
| Manufacturer Postal | 78753 |
| Manufacturer Phone | 7372473605 |
| Manufacturer G1 | ALLERGAN (IRVINE) |
| Manufacturer Street | 2525 DUPONT DRIVE |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYBELLA SKIN GRID |
| Generic Name | MARKER, SKIN |
| Product Code | FZZ |
| Date Received | 2018-07-16 |
| Catalog Number | KYBELLA SKIN GRID |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (IRVINE) |
| Manufacturer Address | 2525 DUPONT DRIVE IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-16 |