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 2018-04-27 for KYBELLA SKIN GRID manufactured by Allergan (irvine).
[106774811]
Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. A review of the device history record has been initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted. The events of? Headaches? ,? Ear pain, ears throb? ,? Lymph nodes below neck and below ear swollen? ,? Throat still hurts? Are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling: 1 indications and usage. 1. 1 fullness associated with submental fat. Kybella? (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. 1. 2 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 dosage and administration. 2. 2 general considerations for administration. Kybella? Should be administered by a healthcare professional. Screen patients for other potential causes of submental convexity/fullness (e. G. , thyromegaly and cervical lymphadenopathy). Give careful consideration to the use of kybella? In patients with excessive skin laxity, prominent platysmal bands or other conditions for which reduction of submental fat may result in an aesthetically undesirable outcome. Use caution in patients who have had prior surgical or aesthetic treatment of the submental area. Changes in anatomy/landmarks or the presence of scar tissue may impact the ability to safely administer kybella? Or to obtain the desired aesthetic result. Kybella? Is clear, colorless and free of particulate matter. Visually inspect kybella? Vials for particulate matter and/or discoloration, and discard the vial if the solution is discolored and/or contains particulate matter. After use, discard any remaining solution in the vial. 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 [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.
Patient Sequence No: 1, Text Type: N, H10
[106774812]
Healthcare professional reported the event of after injection with juv? Derm? Ultra xc in the nasolabial folds and kybella? In the jowls. 2 months later the patient reported headaches, ear pain, lymph nodes below neck and below ear swollen for 2 weeks after injection. Healthcare professional indicated the event was not an ear infection. Patient went to ent specialist who did not find anything. Treatment included antibiotics and doxycycline. Symptoms are ongoing. This is the same event and the same patient reported under mdr id# 3005113652-2018-00467 (allergan complaint #(b)(4)). This is the first mdr submitted for the first suspected product, kybella? Skin grid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024601-2018-00004 |
| MDR Report Key | 7469485 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-27 |
| Date Mfgr Received | 2018-03-30 |
| Date Added to Maude | 2018-04-27 |
| 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 | 2018-04-27 |
| 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 | 2018-04-27 |