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Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Cellulitis (1768); Erythema (1840); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Visual Impairment (2138); Viral Infection (2248); Deformity/ Disfigurement (2360); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/18/2019
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comments: the serious events of infection, abscess, cellulitis, scar at implant site and the non-serious events of mass, pain, erythema, oedema at implant site, cutaneous contour deformity and visual impairment were considered expected and possibly related to the treatment. Serious criteria include the need for multiple medical, surgical interventions and permanent damage. Potential root causes include injection procedure associated with inadequate aseptic technique or high dose of steroid use over short period caused immunodeficiency, making patient susceptible to infections leading to abscess, cellulitis and subsequent manifestations. The serious events of myopathy, musculoskeletal disorder and non-serious events of herpes zoster, hypertension, pain in extremity were considered unexpected and unrelated to the treatment. The likely root cause for these events include high dose of steroid use over short period. The suspected counterfeit restylane was used off label. The case meets the criteria for expedited reporting to the regulatory authorities. Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations. Manufacturer narrative: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure. Lot number was not reported and the product could not be verified. The information in this case does not indicate a non-conforming product or malfunction. The performed investigations are therefore considered adequate and no additional investigations will be conducted.
Event Description
Case reference number (b)(4) is a spontaneous report sent on 11-jan-2021 by a lawyer which refers to a female patient of an unknown age. No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided. On (b)(6) 2019, the patient received treatment with restylane (unknown amount, lot number, injection technique and needle type) for the reduction of glabellar lines between her eyes. The restylane was injected into glabellar lines(off label use of device). Unknown time later, on an unknown date in (b)(6) 2019, the days following the injection by the physician, the patient experienced severe edema(implant site oedema), erythema(implant site erythema), and tenderness(implant site pain) that extended from the injection sight to both eyes causing periorbital edema, with a large hard knot/facial mass(implant site mass) protruding from the injection site between her eyes. The patient's vision impaired(visual impairment), and her face appeared disfigured(cutaneous contour deformity). At the first follow-up with the physician post-injection, he diagnosed the problem as a reaction to the filler vs contact dermatitis and prescribed high dose steroids and an antibiotic. The patient returned to the physician a total of four times between (b)(6) 2020 to (b)(6) 2020, regarding her deteriorating health condition following the initial injection. The physician continued to prescribe high does steroids totaling 840 mg of prednisone [prednisone] in four weeks during the period of treatment, even as the patient's condition continued to worsen including acute hypertension(hypertension). Many times the physician simply called in refills for steroids without personally examining the patient. Meanwhile, the patient sought medical treatment from her primary care physician, who diagnosed her with shingles (herpes zoster) (herpes zoster) on the buttocks relating to becoming immunocompromised from the high doses of steroids, over a short period of time, as prescribed by the physician. On (b)(6) 2020, the patient again sought treatment from the physician for her deteriorating health and advised the physician that emergency medicine specialist, who diagnosed the patient with shingles on the buttocks due to steroids being prescribed in high dosages over a short period of time. The physician charted that the steroids were to be discontinued as a result, then proceeded to give the patient multiple injections of kenalog [triamcinolone acetonide] 40mg/ml into the original injection site in the glabellar lines during his continued treatment of the patient. On (b)(6) 2020, the patient sought care another physician, related to pain in left arm(pain in extremity) and experienced permanent loss of functionality/dysfunction of the left arm(musculoskeletal disorder). The patient was diagnosed with glucocorticoid-induced myopathy/radiating myopathy of left bicep and tricep (myopathy) as a result of high dose oral steroids and injected exogenous corticosteroid over a short period of time. The patient lost muscle control and the functionality of her left arm. The patient has been diagnosed with radiating myopathy of the left bicep and tricep. On (b)(6) 2020, the patient sought treatment due to increasing symptomology radiating from the original injection site. The patient was treated at a urgent care where she was diagnosed with a facial mass, and imaging confirmed a nonspecific 1. 5 cm focal confluent asymmetric soft tissue density in the region of the right nasal bridge to right medial canthus region without deep orbital extension, and a larger regional cellulitis(implant site cellulitis). On (b)(6) 2020, the patient was referred to a plastic surgeon for treatment, who diagnosed the patient with an abscess(implant site abscess) in the glabellar lines resulting from untreated infection (implant site infection) at the injection site. The patient's treatment plan was extensive, including an incision and drainage of the abscess, wound care, weekly then monthly visits, multiple hyaluronidase [hyaluronidase] injections, and antibiotics. The patient now had permanent scarring(implant site scar) on the face, permanent myopathy and dysfunction the left arm resulting from the excessive utilization of steroid treatment by the physician; improper use, administration, and injection of product; and his failure to promptly, and appropriately, treat the complications when initially presented. The physician committed negligence against the patient. He had a duty of care to the patient who sought his advertised medical services, expertise, and/or quality products. He breached the applicable standard of care within a reasonable degree of medical certainty by injecting the product in the wrong location, and/or utilizing a product in the glabellar lines against the manufacturer's suggested use, and/or utilizing a synthetic product from an unknown, source thus violating supply chain integrity. The physician also breached the applicable standard of care, within a reasonable degree of medical certainty, in failing to appropriate treat the patient post-injection administration when complications subsequently arose by failing to properly treat an infection that resulted in cellulitis, further complications, as well as overdosing the patient with steroids, both orally and by injection. The injectable product administered by the physician to the patient injected restylane was suspicious, counterfeit with no quality controls(suspected counterfeit product), recognized by law in the united states, of unverifiable origin, and unsafe to be administered to the patient. The physician further deviated from the applicable standard of care by continuing to negligently inject the patient's glabellar lines, and original injection site, with steroids even after he determined to discontinue steroids after being informed of the patient adverse reaction to steroids. As a result of the above-described negligence, wrongful, acts, and/or omissions of the physician, the patient suffered damage in the form of serious and lasting injuries to her body, some of which have caused severe pain and suffering of the body and mind; resulted in loss of income and employability, resulted in the incurrence of additional medical related, expenses in the past, present and future; and has manifested in permanent impairment of the patient's body. Said amount of damages exceeds the jurisdictional requirements of the court. As a direct and proximate result of the above-described negligence, wrongful acts, and/or omissions of the physician, the patient suffered a loss of ability to engage in her usual activities of daily living; and she expects to continue to suffer a loss of ability to engage in her usual activities of daily life, which was permanent and continuing, and which was expected to continue to be suffered in the future. Such damages exceed the jurisdictional requirements of the court. Outcome at the time of the report: infection was unknown. Abscess was unknown. Cellulitis was unknown. Permanent scarring was not recovered/not resolved. Permanent loss of functionality/dysfunction of the left arm was not recovered/not resolved. Glucocorticoid-induced myopathy/radiating myopathy of left bicep and tricep was not recovered/not resolved. Edema was unknown. Erythema was unknown. Tenderness was unknown. Large hard knot/facial mass was unknown. Vision impaired was unknown. Face appeared disfigured was unknown. Acute hypertension was unknown. Shingles (herpes zoster) was unknown. Pain in left arm was unknown. Restylane was injected into glabellar lines was recovered/resolved. Injected restylane was suspicious, counterfeit wit no quality controls was recovered/resolved.
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Manufacturer (Section D)
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
MDR Report Key11230656
MDR Text Key232840531
Report Number1000118068-2021-00003
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/26/2021
Distributor Facility Aware Date01/11/2021
Event Location Other
Date Report to Manufacturer01/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/26/2021 Patient Sequence Number: 1