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Lot Number 16418-2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Purulent Discharge (1812); Edema (1820); Erythema (1840); Granuloma (1876); Skin Inflammation (2443); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comment: the serious event of abscess at the implant site was considered possibly related to the treatment. Serious criteria included the need for multiple medical interventions to prevent permanent damage. The non-serious, expected events of erythema, oedema, induration and inflammation at the implant site, purulent discharge, granuloma skin, and the unexpected event of scab at injection site were considered possibly related to the treatment. Potential contributory factor include injection technique. The case meets the criteria for expedited reporting to the regulatory authorities. Capa comment: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action. Manufacturer narrative: lot number was not reported.
Event Description
Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2020 by a physician which refers to a (b)(6) female patient. Additional information was received on 24-jan-2020 and 27-jan-2020 from the physician via medical advisor by phone call or email. It was reported as non-serious case. No information about medical history, concomitant medication or history of allergies has been provided. The patient had never received injections of fillers before. On an unknown date in (b)(6) 2020, the patient received treatment with 1 ml restylane to nasolabial folds as aesthetic treatment against wrinkles (unknown lot number, injection technique and needle type). Immediately after the treatment, the physician decided to apply a zinc oxide cream at the injection sites. Three days after the treatment, the patient referred a good aesthetic result without complaining any issue. 7 days later, on an unknown date in (b)(6) 2020 after the treatment with restylane, there was the appearance of erythema/violet-coloured redness(implant site erythema), oedema (implant site oedema) and hardening (implant site induration) along almost the whole right nasolabial fold which evolved after about three days into two abscess nodules (implant site abscess) along the nasolabial fold. The reporting physician visited the patient on (b)(6) 2020 and she noticed the presence of 2 abscesses with intense inflammation (implant site inflammation) and hardening on the right nasolabial fold. One of these two abscesses, after being touched softly, released pus (purulent discharge). Moreover, the physician noticed the presence of oedema and erythema in the upper part of the left nasolabial fold. On (b)(6) 2020, the reporting physician started a therapy with augmentin (amoxicillin, clavulanic acid) 2 tablets orally, daily, rocefin [ceftriaxone sodium], 1000 mg, 1 vial daily, intramuscular and to monitor daily patients conditions. On (b)(6) 2020, the reporting physician started also an anti-inflammation therapy with brufen [ibuprofen], 1 tablet, daily, orally. At the time of reporting, the prescribed therapy was still ongoing, with a remarkable improvement of the oedema and erythema on the right nasolabial fold. The physician, however, noticed the persistence of a violet-coloured redness in correspondence to the previous abscesses, that at the time of reporting they were covered by squamous crusty formation(injection site scab), persistence of hardening at palpation along the right and left nasolabial folds, in the upper part of them. The patient conditions were clearly improving, but the hardening at palpation was persisting. As reported by the physician, there were still silent granulomas (granuloma skin). The physician changed antibiotic and she introduced since some days a cortisone-based drug nos [corticosteroid nos] not otherwise specified oral. This cortisone-based drug was still ongoing at the time of reporting. At the time of reporting, the outcome of the adverse events were considered as improving for erythema and for oedema, ongoing for hardening and abscess. Outcome at the time of the report: abscess nodules was not recovered/not resolved. Erythema/violet-coloured redness was recovering/resolving. Oedema was recovering/resolving. Hardening was not recovered/not resolved. Released pus was unknown. Intense inflammation was unknown. Squamous crusty formation was not recovered/not resolved. Silent granulomas was not recovered/not resolved.
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Manufacturer (Section D)
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer (Section G)
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
Manufacturer Contact
randy russell
14501 n. freeway
fort worth, tx, TX 76177
MDR Report Key9722255
MDR Text Key192493872
Report Number9710154-2020-00032
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number16418-2
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/18/2020 Patient Sequence Number: 1