MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-12-14 for KYBELLA SKIN GRID manufactured by Allergan (irvine).
[94814700]
The event of? Nerve was hit and now she has a crooked smile? Is a physiological/procedural complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. Device labeling: 2 dosage and administration. 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. Health care 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 [see warnings and precautions (5)]. 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 [see warnings and precautions (5. 1)]. 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. Avoid injection into the platysma. Prior to each treatment session, palpate the submental area to ensure sufficient submental fat and to identify subcutaneous fat between the dermis and platysma (pre-platysmal fat) within the target treatment area (figure 2). The number of injections and the number of treatments should be tailored to the individual patient? S submental fat distribution and treatment goals. Injecting into the treatment area. Use of ice/cold packs, topical and/or injectable local anesthesia (e. G. , lidocaine) may enhance patient comfort. Outline the planned treatment area with a surgical pen and apply a 1 cm injection grid to mark the injection sites (figures 2 and 3). Do not inject kybella outside the defined parameters [see warnings and precautions (5. 1, 5. 4)]. 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. Do not withdraw the needle from the subcutaneous fat during injection as this could increase the risk of intradermal exposure and potential skin ulceration. 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. Warnings and precautions: marginal mandibular nerve injury. Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness (paresis), were reported during clinical trials. To avoid the potential for nerve injury, kybella should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days). Dysphagia: difficulty swallowing (dysphagia) occurred in clinical trials in the setting of administration site reactions, e. G. , pain, swelling, and induration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Subjects with current or prior history of dysphagia were excluded from clinical trials. Avoid use of kybella in these patients as current or prior history of dysphagia may exacerbate the condition. Risk of injecting in proximity to vulnerable anatomic structures: to avoid potential tissue damage, kybella should not be injected into or in close proximity (1-1. 5 cm) to salivary glands, lymph nodes and muscles. Adverse reactions: table 1. Adverse reactions in the pooled trials 1 and 2a. The most commonly reported adverse reactions include: edema/swelling, hematoma/bruising, pain, numbness, erythema, induration, paresthesia, nodule, pruritus, skin tightness, site warmth, nerve injury, headache, oropharyngeal pain, hypertension, nausea, and dysphagia. Other adverse reactions associated with the use of kybella include: injection site hemorrhage, injection site discoloration, pre-syncope/syncope, lymphadenopathy, injection site urticaria and neck pain.
Patient Sequence No: 1, Text Type: N, H10
[94814701]
Patient reported the event of after injection for the treatment of submental fat with kybella? The patient stated that their nerve was hit and now they have a crooked smile. The kybella? Skin grid was used. No treatment has been provided. The patient also stated that she received kybella? Once about a year ago with no issues. No indication provided if there was resolution for the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024601-2017-00013 |
| MDR Report Key | 7116811 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-12-14 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-11-13 |
| Date Mfgr Received | 2017-11-14 |
| Date Added to Maude | 2017-12-14 |
| 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 | 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 | 2017-12-14 |
| 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. Required No Informationntervention | 2017-12-14 |