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 2017-10-10 for KYBELLA SKIN GRID manufactured by Allergan (irvine).
[89187119]
(b)(4). Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events of nerve damage, dent, hanging wrinkly skin, distressed, skin got inflamed and disfigurement are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. Device labeling for the reported events: warnings and precautions: for topical use only. Do no inject through the transferred grid markings. Do not use on broke or damaged skin.
Patient Sequence No: 1, Text Type: N, H10
[89187120]
Patient reported being injected with kybella by a doctor and had been left with "nerve damage which is not resolving after 6 weeks" and "a dent" on their neck with "two bits of hanging wrinkly skin" that "will need cosmetic surgery correction. " patient was distressed and claimed that the product has left the patient with "disfigurement. " the patient noted they could not smile and that their "face skin got inflamed" as well as their lips. Patient had gone to the emergency room which informed the patient of having nerve damage. Patient notes the shape of their face is different than before and is not better. Patient still has all symptoms and sagging skin. It is unknown if the skin grid was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024601-2017-00007 |
| MDR Report Key | 6938536 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-10-10 |
| Date of Report | 2017-10-10 |
| Date Mfgr Received | 2017-09-11 |
| Date Added to Maude | 2017-10-10 |
| 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 | 2017-10-10 |
| 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 | 2017-10-10 |