MAUDE Adverse Event Report: UNKNOWN MANUFACTURER UNK DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number UNK DERMAL FILLER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Skin Irritation (2076); Blood Loss (2597)

Event Date 03/04/2019

Event Type  Injury  

Manufacturer Narrative

In response to fda report number mw5086293.Concomitant medical products: probiotics, zyrtec.(b)(4).The event is a physiological 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.This is a known potential adverse event addressed in the product labeling.

Event Description

Physician reported to have injected a patient in the in the midface and outer cheeks with one syringe of juvéderm® vollure® xc.About 4 months later, the patient developed a larger nodule "around the left upper quadrant, left zygoma¿ and the patient has smaller nodules in the other injected areas.The night before the patient started experiencing these adverse events, the patient went to a sauna and "sweated a lot." the physician has not physically examined the patient, and has only seen photos and been corresponding with the patient via phone.4 days later and on the following day, the patient went to the primary care physician, and received prednisone and an injectable steroid due to fear of "granuloma." the alleged ¿granuloma¿ has not been confirmed via biopsy.The physician indicated the patient may need a hyaluronidase treatment.The patient takes ¿thyroid medication¿ concomitantly.Additionally, the patient reported to have been injected on the year of the date of onset with an unspecified dermal product for which the manufacturer is unknown.On the date of onset, the patient ¿noticed a hard nodule (the size of a quarter) growing on the cheekbone near the temple.¿ the patient also reported ¿another nodule appeared on the right side, same place¿, ¿a new nodule on the left side of the chin.Cheekbone nodules were spreading around the eyes, nose, up the temples, and on the cheeks, causing pressure, pain, and disfigurement.All nodules began at the injection sites.¿ the patient reported to ¿still¿ be on prednisone.The patient specified that the steroid treatment was performed upon referral to dermatology.The treatment consisted of ¿2 steroid injections into 2 nodules on the left side of the face as test.¿ the ¿symptoms worsened giving cause to believe there was a biofilm infection.¿ no diagnosis of infection was provided.The patient saw a dermatology specialist who prescribed antibiotics, but refused to treat the patient with hyaluronidase due to lack of medical records and information of the product used.The patient went back to the injector¿s office and spoke to a registered nurse (rn) ¿with no experience in hyaluronidase injection¿.The rn ¿was reluctant¿ to treat the patient and advised to continue the prednisone, then switched to antibiotics, per the physician¿s instruction.The patient was later admitted to the er ¿due to severe pain in the face, fluid filled sacks under [the] eyes, nodules appearing in the corners of the eyes impacting vision, and disfigurement.¿ the patient alleged to have been ¿unrecognizable.¿ the er did a ct scan of the face to reveal ¿granulomatous disorder of the skin and subcutaneous tissues, unspecified.¿ the patient received a steroid injection ¿into their quad¿ before release.The er also refused to treat the patient with hyaluronidase, ¿due to the same reason [the] dermatology specialist gave¿.The patient reported then seeing the injector and being injected with hyaluronidase ¿in the left nodule.¿ the patient received more hyaluronidase at a later time.The patient reported that the ¿swelling [is] going down[,] but comes and goes randomly.Nodules are still there and spreading to other areas in the face and lips.New symptoms of blood in the stool.Still soaking sheets at night.¿ a blood test is wanted ¿due to blood found in stool¿.The patient takes cymbalta for fibromyalgia, levothyroxine for thyroid, daily vitamins, probiotics, and zyrtec, which the patient has stopped.The patient alleged ¿hospitalization, disability/permanent damage, required intervention¿ as the event outcome.This is the same event and the same patient reported under mdr id # 3005113652-2019-00381 (allergan complaint # (b)(4)).This mdr is being submitted for the second suspect product, unspecified dermal product, for which the manufacturer is unknown.

• Brand Name: UNK DERMAL FILLER
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): UNKNOWN MANUFACTURER
• Manufacturer (Section G): UNKNOWN MANUFACTURER
• Manufacturer Contact: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8582855
• MDR Text Key: 144155039
• Report Number: 3005113652-2019-00382
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P800022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK DERMAL FILLER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CYMBALTA, LEVOTHYROXINE, DAILY VITAMINS
• Patient Outcome(s): Hospitalization; Required Intervention; Disability