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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HR PHARMACEUTICALS INC. SURGILUBE; LUBRICANT, PATIENT
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HR PHARMACEUTICALS INC. SURGILUBE; LUBRICANT, PATIENT Back to Search Results
Lot Number 19458
Health Effect - Clinical Codes Itching Sensation (1943); Burning Sensation (2146); Swelling/ Edema (4577)
Date of Event 11/07/2024
Type of Reportable Event Serious Injury
Event or Problem Description
My gynecologist used "surgilube" which contains chlorhexidine gulonate during my pap smear procedure.By the time i got dressed, my entire body had uncontrollable itching, especially in the vaginal area.The body itching has subsided after a week, however the vaginal area inside and out is still itching, swollen, and burning.Some information that i have read online says it's not recommended for that procedure, yet it is used, and the side effects are horrible.I hope they will remove it for this procedure.My gynecologist used it to perform a pap smear exam.
 
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Brand Name
SURGILUBE
Common Device Name
LUBRICANT, PATIENT
Manufacturer (Section D)
HR PHARMACEUTICALS INC.
MDR Report Key20724194
Report NumberMW5162637
Device Sequence Number16092940
Product Code KMJ
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 11/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot Number19458
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/18/2024
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
5-HTP; BIO INFLAMAX ; CALCIUM CITRATE; COLLAGEN; D3-K2; L-TYROSINE ; MAGNESIUM CITRATE ; PROBIOTIC; TUNA OIL ; ZINC
Outcome Attributed to Adverse Event Other;
Patient Age62 YR
Patient SexFemale
Patient Weight49 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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