Model Number MODERATE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Itching Sensation (1943); Skin Irritation (2076); Fungal Infection (2419)
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Event Date 01/01/1999 |
Event Type
Injury
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Manufacturer Narrative
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A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.
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Event Description
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Consumer reported she has been experiencing yeast infections for the last 20 years while using the product.The yeast infection traveled to the inside of her stomach and she was hospitalized.She recently sought medical attention for a red itchy rash in vaginal area.Medication was prescribed for yeast infection.Upon completing the medication her symptoms improved but did not resolve.She is currently taking prednisone.
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Manufacturer Narrative
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This is a follow up to report new information was received from the consumer.Consumer reported she had not been hospitalized due to her yeast infections.Report type: follow-up 1.
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Event Description
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This is a follow-up to report new information was received from the consumer.Consumer reported she had not been hospitalized due to her yeast infections.
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Search Alerts/Recalls
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