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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Visual Impairment (2138)
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Event Date 06/23/2017 |
Event Type
Injury
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Manufacturer Narrative
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Corrected data: (b)(4).
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2017 by a physician which refers to a female patient.The patient's medical history included: idiopathic optic neuropathy.Concomitant medication and allergies were not reported.The patient also received treatment with volbella on (b)(6) 2017 to lips.On (b)(6) 2017, the patient received treatment with 2 ml restylane refyne (lot unknown) to cheek and 2 ml restylane lyft with lidocaine (lot unknown) to temple with unknown needle and unknown technique.The patient tolerated the procedures well and returned for follow-up two days later with no swelling or bruising.She was looked with a led light.On (b)(6) 2017 the patient contacted the physician to report that on an unknown date she had experienced vision problems(visual impairment).Patient visited a hospital and was in the er (emergency room) three times, including on (b)(6) 2017.Outcome at the time of the report: vision problems was not recovered/not resolved.
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Manufacturer Narrative
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Corrected data: this report was initially submitted as an importer and manufacturer mdr with importer number as the leading submission number.At the time of the submission, galderma had a waiver allowing the submission of one report as both the manufacturer and importer report.The follow up one to the initial report was then submitted as both the manufacturer and importer report, but the manufacturer report number led the sequence.All of the information received for both the initial and follow-up submissions were included in the appropriate submissions, no new information has been received at this time.However, to correct the sequence numbers for this mdr this manufacturer report will be submitted to nullify the report sequence.All information in this case will be appropriately reported in a new sequence number 9710154-2017-00103 (0).In addition, the follow-up one sequence for the importer report will also be submitted to correct the sequence number.This correction follows receipt of an email from the fda.
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on 23-jun-2017, with additional information received on 21-jul-2017, from a physician which refers to a 67 year old female patient.The patient's medical history included: idiopathic optic neuropathy.The reporting physician stated she believed the patient had multiple sclerosis, but was awaiting a final diagnosis.Concomitant medication and allergies were not reported.The patient also received treatment with volbella on (b)(6) 2017 to lips.On (b)(6) 2017, the patient received treatment with 2 ml of restylane refyne (lot unknown) to the mid-cheeks and 2 ml of restylane lyft with lidocaine (lot unknown) to the temples with the provided needle and unknown technique.Product was retracted before the injection.The patient tolerated the procedures well and returned for follow-up two days later with no swelling or bruising.She was looked with a led light.On (b)(6) 2017, the patient contacted the physician to report that on an unknown date she had experienced vision problems(visual impairment).The reporting physician stated the patient verbalized the event, however the patient was not seen by the physician.Patient visited a hospital and was in the er (emergency room) three times, including on (b)(6) 2017.Outcome at the time of the report: vision problems was not recovered/not resolved.Tracking list (b)(4) (b)(6) 2017: patient age, medical history, er date, and needle type updated.
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Search Alerts/Recalls
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