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Catalog Number 96637JR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Skin Irritation (2076)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Clarification: the filler was injected into the patient and is not accessible for return. The syringe was not returned for evaluation. 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. This is a known potential adverse event addressed in the product labeling.
Event Description
Patient reports injection with 2 syringes of juvéderm® voluma¿ with lidocaine and 1 syringe of juvéderm® volux¿ in the chin, lips, and to a few points on the nose. Patient was told there were no risks. Per patient, "it looked beautiful at that moment, but there was slight pain caused by the sensitivity of the needles and the pressing to the fillers. " patient advised not to apply water to the area for 2 days and to drink plenty of water. The following day, lips were swollen and chin was hard like concrete. Per injector, this is a normal process. The next day, patient couldn't sleep at night because of jaw ache. Patient noted that the chin was stiff like concrete, tight, swollen and aching. Patient took apranax fort (naproxen). Pain and aches were reduced with the effect of the painkiller. When effect was over, pain returned. The next day, there was an eye-sized mass, a hard swelling and oedema on the left cheek and under the chin. When observed, my jaw was very hard and tense and patient had difficulty speaking, heat was given with radiofrequency, however because the treating physician pressed a little the head was not felt. The skin was burnt, red and very painful. Patient again could not sleep due to pain, aches and burning. The following day, chin was very red and overly tense when patient woke up. Patient told the hcp that they felt the chin was ¿going to explode and something is going to gush out of it¿ and suspected inflammation. Per hcp, this is normal, there is no inflammation, only oedema. Patient was having difficulty speaking and returned to the clinic for extreme pain. Patient was injected with cortisone in the hip for pain relief and edema reduction. Per patient, it was stinging through the inside of lips and gums. Burning, pain, aching, difficulty speaking and tingling continued all day and kept patient awake at night. The next day, the face was completely swollen, patient could not bear the pain, [area] was hard like concrete, swollen and painful. Patient was concerned ¿there could be something wrong. ¿ patient requested hyaluronidase to melt the filler. Hcp advised patient not to apply hyaluronidase as this event was a ¿normal process that will swell, it will be pretty. ¿ hyaluronidase injected as patient could not bear the pain. Hyaluronidase did not show effect until 3-4 days later and there was no changes next day. Agumentin (amoxicillin + clavulonic acid) and coraspirin (acetylsalicylic acid) prescribed. The next day, pain and burning increased in the afternoon. Patient went to bed and woke up 1. 5 hours later due to aching, burning and painful jaw area, gums and lips. Patient used a fan for relied, but could no sleep until 3. 5 hours later. Painkillers were taken and patient was able to fall asleep. The following day, the chin was overly tense, it was red and pimple-like inflammation was on a few points, but after a while, inflammation began to flow to the neck while patient was sitting. Large amount of inflammation flowed from my chin spontaneously at home and patient returned to the doctor. Doctor cleaned the inflammation with antibiotic liquid and said that it is very bad, ¿microfilm¿ occurred and ¿infection from outside to inside. ¿ patient experienced relief as the inflammation flowed. The next day, inflammation, constantly flowed from other points. There was pain in the jaw all day long. Culture and blood analysis completed for the inflammation in the jaw the following day. Another unspecified doctor said that inflammation was also present in the nose and should be cleaned well. Patient returned to injecting hcp and the inflamed area on the chin was cleared and hyaluronidase was injected into the nose. The next day, patient spoke to the hcp and expressed complaints. Patient was advised to wait a little longer as it will swell and later it will go down. Patient had pain in the chin, swelling in the left chin and hardness throughout the day. Nose was hurting (upper nose and lip joint) and patient could no wipe it. Lips were also peeling badly, [area] was hard, upper crust was swollen and patient experienced severe pain. Top and bottom lips could not be put together or puckered up. Spills out of the mouth when patient eats or drinks water as patient could not control it due to swelling, pain and aching. The next day, top of the nose, lips and lip joints hurt badly. Patient could not gargle or drink water with a straw. Swelling and stiffness of the left cheek continues and there is pain present in the jaw and aching of the teeth. Unspecified hcp and injector examined left side and nose swelling with hand and squeezed the inflammation out. Hyaluronidase injected to area connecting lip and nose and inflammation gushed out when the needle was removed. Inflammation also came from the lip. The next day, there is tingling and tension like when the procedure was done and the gums are aching. The following day, injector accused patient of placing ice on the area. According to patient, no application of anything without permission from hcp. Patient advised not to use ice to reduce edema, but told to use a hot towel. Hcp told patient to wait 1 week to 10 days, but patient was hurt and had inflammation on the tip of the lip. A cream was applied to numb and the inflammations of the lip, nose and left cheek were cleared. Patient was contacted for control 2 days later. The next day, inflammation flowed spontaneously from the lips and above the nose. Medication taken , cream applied the next day and inflammation accumulated at the tip of the nose. No pain/ache. Additional treatment noted as klindan 150 mg (clindamycin), bemix (vitamin b complex) and bactroban krem (mupirocin). Patient experienced psychological trauma and sadness, social pressure and physical trauma as a result of this event. Event has not been resolved.
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Manufacturer (Section D)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer (Section G)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer Contact
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
MDR Report Key10979055
Report Number3005113652-2020-00741
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2022
Device Catalogue Number96637JR
Device Lot NumberVB20B00439
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Outcome(s) Required Intervention;