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Lot Number 18945
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Rash (2033); Obstruction/Occlusion (2422); Pallor (2468); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/27/2021
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comment: the serious events of necrosis at implant site, vascular occlusion, the non-serious events of pain, swelling, erythema and pallor at implant site were considered expected and possibly related to the treatment. Serious criteria included the need for multiple medical interventions. The likely root cause include the injection procedure and intravascular filler injection leading to vascular occlusion and its manifestations. The non-serious event of rash was considered unexpected and unrelated to the treatment. Alternative etiology include corrective treatment with hylase. 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. Maufacturer 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. The reported lot number was valid and verified the reported product. 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 (b)(6) 2021 by a physician which refers to a female patient of an unknown age. Additional information was received on same day from same reporter. No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided. On (b)(6) 2021, the patient had come to physician requesting for upper lip filler. The physician discussed about filler side effects and complications and took consent form signed from patient. On examination, noticed upper lip was thin and lower lip was thick. On (b)(6) 2021, the patient received treatment with 1 ml restylane lidocaine (lot 18945), 0. 3 ml to right and 0. 7 ml to left side of upper lip with unknown needle type and injection technique. About 5-10 min after, on (b)(6) 2021, the patient had swelling(implant site swelling) in left upper lip and the ice was applied immediately in assisting reduction of swelling. The icing was used for an hour and was also given immediately antihistamine telfast [fexofenadine hydrochloride] 180 mg for same purpose. After 1 and half hour trying to monitor swelling, patient was still stressed and a little bit of pain(implant site pain). They discussed about injecting small amount of hyalase to see if swelling improves. Assisted with small amount of laser of 1. 64 nm wavelength. The patient was still stressed, so injected with 0. 3 ml hylase [hyaluronidase] to left upper lip. The hylase 1 vial was mixed with 10 ml saline [sodium chloride]. The patient was asked to contact 24 x 7 if any issue. At night 6 to 7 pm, the patient had contacted the physician and sent photo. The photos appeared well with reduction in swelling. On (b)(6) 2021 morning, the patient had contacted the physician and sent photo. There was white slough(implant site necrosis) seen on left upper lip and patient was asked to come back for review. The physician reviewed patient's upper lip, swelling was reduced and slight redness(implant site erythema) was there along with line of whiteness/blanching (implant site pallor). The physician suspected vascular occlusion(vascular occlusion), blanching or post hylase rash(rash). The patient was advised to use chloring ointment tds and further review. The patient was asked to come for review with another physician, but patient failed to turn up for follow up. Outcome at the time of the report: white slough was unknown. Suspected vascular occlusion was unknown. Swelling was recovering/resolving. Painful was unknown. Line of whiteness/blanching was unknown. Post hylase rash was unknown. Slight redness was unknown.
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Manufacturer (Section D)
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
Manufacturer (Section G)
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
Manufacturer Contact
randy russell
14501 north freeway
fort worth, TX 76177
MDR Report Key11787702
MDR Text Key264559597
Report Number9710154-2021-00024
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeAS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number18945
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2021
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 Unkown

Patient Treatment Data
Date Received: 05/06/2021 Patient Sequence Number: 1