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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Dyspnea (1816); Erythema (1840); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Scarring (2061); Skin Erosion (2075); Swelling (2091); Tachycardia (2095); Vomiting (2144); Discharge (2225); Discomfort (2330); Pallor (2468); No Code Available (3191)
Event Date 06/01/2019
Event Type  Injury  
Event Description
Case reference number (b)(4) is a spontaneous report sent on 02-dec-2019 by a (b)(6) female patient concerning herself. The patient's medical history included hypothyroidism, anxiety, asthma, chronic pain and insomnia. Concomitant treatments included alprazolam [alprazolam] 0. 5 mg daily, levothyroxine [levothyroxine] 75 mcg daily, zolpidem [zolpidem] 6. 25 mg daily and trelegy ellipta (fluticasone, umeclidinium, and vilanterol) inhaler one puff daily. The patient had previously received treatment with unspecified filler in both sides of her forehead in 2017 for cosmetic reasons. In (b)(6) 2019, the patient received treatment with restylane injection, in her nasolabial folds and on both sides of her forehead (unknown amount, lot number, injection technique and needle type). The patient reported that she was not having any adverse event until (b)(6) 2019. On (b)(6) 2019, the patient noticed a cylindrical mass (implant site mass) on the right outside of her nostril and a similar mass on left side in her gum (mass) which could be felt but not seen. The patient felt sensation of skin separating from bone (paraesthesia) on the right side of her face at that time and she felt like her right brain was fighting her left brain. Eventually in (b)(6) 2019, patient had an eruption (implant site rash) with drainage (implant site discharge) on right side partially white (implant site pallor), and partially redness (implant site erythema) and bleeding (implant site haemorrhage), and was seen in the emergency room on (b)(6) 2019. On same day, the patient received an injection of unspecified steroids but the emergency room doctor was unsure of actual diagnosis. On (b)(6) 2019, she again went to the emergency room (second visit) and obtained an oral unspecified antibiotic and mupirocin [mupirocin] ointment as treatment after experiencing draining (implant site discharge) and numbing (implant site hypoaesthesia) and loss of muscle control (muscle disorder) in the area of the eruption on the right outside of her nostril. The patient also had her eyes swollen (eye swelling) at this point of time. In (b)(6) 2019, the patient developed loss of voice (aphonia) after her second emergency room visit. On (b)(6) 2019, she again went to the emergency room for the same eruption and received a prescription for clindamycin [clindamycin] and mupirocin [mupirocin] ointment. The loss of voice was resolving by the third emergency room visit, on (b)(6) 2019, the patient went to emergency room and stated they thought she had a staph infection but the culture was negative. It was stated that it was possibly due to prior antibiotics. The patient was admitted overnight and received one dose of vancomycin [vancomycin], intravenously. The patient had seen primary care physician, and dentist in 2019 for denture problems due to gum pain (gingival pain). Recently a dermatologist told her she only had scar tissue/pock marks (implant site scar) on the right side of her face, an erosion/hole (implant site erosion) on the left side of her face the size of a pin, near the nasolabial area. She stated that she now had pain in her face on the right side by her gum and by her right eye (implant site pain) and pressure in her face and pressure by right side of gum and by her right eye (injection site discomfort). In 2019, the patient also experienced lack of appetite (decreased appetite), unpleasant taste in mouth (taste disorder), mucous/sinus problems (sinus congestion), white bouncy discharge from left nostril (rhinorrhoea), trouble breathing (dyspnoea) that went into coughing fits, coughing up mucous (productive cough), periodically the patient had elevated pulse, up to 154 beats/min, nausea(nausea), vomiting (vomiting), loose stools (diarrhoea), wavy abdomen in the areas surrounding old surgical scars, whole body squirming (muscle twitching), occasional dry mouth (dry mouth), gum symptoms which prevent her from wearing dentures, a moveable mass neck (neck mass) noted on (b)(6) 2019 which was getting smaller, eye irritation (eye irritation) and eye twitching (blepharospasm) brought on by exposure to wind, tachycardia (tachycardia) and laryngitis (laryngitis). The reporter attributed the adverse events that had occurred since (b)(6) 2019 to restylane and stated that everything else had ruled out. Outcome at the time of the report: (eruption) with drainage was recovered/resolved. Eruption with (drainage) was recovered/resolved. Eruption on right side partially white was recovered/resolved. Eruption on right side partially red was recovered/resolved. Bleeding was recovered/resolved. Numbing was recovered/resolved. Loss of muscle control was recovered/resolved. Cylindrical mass was unknown. Mass on left side in her gums was unknown. Erosion/hole was not recovered/not resolved. Scar tissue / pock marks was not recovered/not resolved. Eyes swollen was unknown. Pressure in her face on the right side by her gum and by her right eye was unknown. Mucous/sinus problems was unknown. Coughing fits, coughing up mucous was unknown. Dry mouth was unknown. Pain in her face on the right side by her gum and by her right eye was unknown. Loss of voice was recovering/resolving. Nausea was unknown. Vomiting was unknown. Unpleasant taste in mouth was unknown. Lack of appetite was unknown. Sensation of skin separating from bone was recovered/resolved. Mass neck was recovering/resolving. Loose stools was unknown. Whole body squirming was unknown. Gum pain was unknown. Eye irritation was unknown. Eye twitching was unknown. White bouncy discharge from left nostril was unknown. Tachycardia was unknown. Trouble breathing was unknown. Laryngitis was unknown.
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Manufacturer (Section D)
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
MDR Report Key9495349
MDR Text Key188201678
Report Number1000118068-2019-00018
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,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/30/2020
Distributor Facility Aware Date01/08/2020
Event Location Other
Date Report to Manufacturer01/08/2020
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: 12/19/2019 Patient Sequence Number: 1