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Lot Number 16240
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Swelling (2091); Reaction (2414)
Event Date 04/01/2019
Event Type  Injury  
Manufacturer Narrative
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. Mfr. Narrative: the reported lot number was valid. The serious events of mass and reaction at the implant site, and the non-serious events of swelling and pain at the implant site and intentional device misuse were considered expected and possibly related to the treatment. Serious criteria included the need for surgical lumpectomy and multiple medical interventions with steroid, hyaluronidase and antibiotic injections and oral antibiotics to prevent permanent damage. The non-serious events of dryness and exfoliation at implant site were considered unexpected and possibly related to the treatment. Potential etiologies include hypersensitivity, inflammatory reaction and infection. Potential contributory factors include injection technique, interactions with previous implants and skin or dental changes associated with concomitant hormonal therapy. The case meets the seriousness criteria for expedited reporting to the regulatory authorities.
Event Description
Case reference number (b)(6) is a spontaneous report sent on 17-jun-2019 by a (b)(6)-year-old female patient concerning herself. Additional information was also received from the physician. The patient medical history included endometriosis. Concomitant treatments included birth control medication [contraceptives]. The patient had previously received treatment with juvederm and botox. On (b)(6) 2019, the patient received treatment with 0. 9 ml restylane defyne (lot 16240) to upper and lower lips with 27g needle and straight technique. On (b)(6) 2019, same day after the treatment, the patient experienced severe swelling (implant site swelling) and painful to touch (implant site pain) at lips. The patient reported had bad reaction to the filler (implant site reaction). On (b)(6) 2019, the patient came for a touch up treatment on cupid bows and the remainder 0. 1 ml was injected(intentional device misuse). On (b)(6) 2019, the patient experienced two severe bubble like lump/whitish bumps (implant site mass) all over top lip and lower lip. It was reported that, patient had one bump after the first session and two weeks later the pain increased and bumps surrounded her whole mouth. On an unknown date in (b)(6) 2019, the patient had dry (injection site dryness) and peeling (implant site exfoliation) at lips. As corrective treatment the patient tried to massage the lumps but it was too painful to touch. The physician also offered steroids but the patient initially declined. On unknown dates in 2019, the patient received three sessions of unspecified dissolver put into lips, 2 rounds of steroids injected into lips and 2 rounds of antibiotics injected as well. The patient was also on unspecified antibiotics since a month back and continued to take it. However, the patient continued to have painful bumps. The patient could barely eat as it was painful to bite down and have her lips touch things. On (b)(6) 2019, the patient visited a triple board certified plastic facial and reconstruction surgeon yesterday ((b)(6) 2019) who actually had to cut some of the bumps out and put stitches in. The photos of the adverse events was received on 06-aug-2019. Outcome at the time of the report: swelling was recovered/resolved. Painful to touch was not recovered/not resolved. Bad reaction to the filler was not recovered/not resolved. Bubble like lump/whitish bumps was not recovered/not resolved. Dry was not recovered/not resolved. Peeling was not recovered/not resolved. The remainder 0. 1 ml was injected was unknown. Tracking list: v. 0 initial. V. 1 fu received on 06-aug-2019 from the consumer along with photos of the adverse events. Corrective treatments were provided. Event outcome of swelling event was updated. Event of intentional device misuse was added. The case was upgraded to serious due to required surgical and medical intervention.
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Manufacturer (Section D)
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28
MDR Report Key8965002
MDR Text Key161092635
Report Number1000118068-2019-00008
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
Type of Report Initial
Report Date 09/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number16240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/05/2019
Distributor Facility Aware Date08/06/2019
Event Location Other
Date Report to Manufacturer08/06/2019
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?
Type of Device Usage

Patient Treatment Data
Date Received: 09/05/2019 Patient Sequence Number: 1