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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROCTER & GAMBLE INC ALWAYSPADSULTRATHINULTRABASEVERWINGLONGNONDO; PAD, MENSTRUAL, UNSCENTED

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PROCTER & GAMBLE INC ALWAYSPADSULTRATHINULTRABASEVERWINGLONGNONDO; PAD, MENSTRUAL, UNSCENTED Back to Search Results
Lot Number 61837786401830283
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Urinary Tract Infection (2120); Burning Sensation (2146); Hematuria (2558)
Event Type  Injury  
Manufacturer Narrative
Return of product has been requested.A lot number was provided by the reporter.Full evaluation will occur upon receipt of returned product.This case was initially submitted on 31-may-2017 with the incorrect mfr report # of 8022158-2017-00001.This corrected initial submission has the accurate mfr report number.
 
Event Description
Bladder infection [cystitis], urinary tract infection [urinary tract infection], urinating blood [haematuria], allergic to the pads [hypersensitivity], spotted red rash all over private area-female genital [genital rash], burning sensation all over private area-female genital [genital burning sensation], itching all over private area-female genital [pruritus genital], rash in pad area [medical device site rash], burning sensation in pad area [medical device site paraesthesia], itching in pad area [medical device site pruritus], allergic broke out from pads [medical device site hypersensitivity].Case description: a (b)(6) female consumer reported via phone on (b)(6) 2017 that she used always pads ultra thin ultra base version wing long non deodorant 1 pad, 4 times a day ending two and half weeks ago on (b)(6) 2017 and she was allergic to them.She clarified that she initially experienced a red spotted rash in the area of the pad (genital/private area), had a burning sensation, and itching.She asserted that on the third day of experiencing the rash, she started urinating blood, called her physician, who advised her to go to the emergency room.According to the consumer, she was admitted to the hospital for four days with a bladder infection and urinary tract infection.Treatment consisted of antibiotics intravenously while in the hospital.Also, she had to go back to the hospital for intravenous antibiotics as an outpatient afterwards.Product use was discontinued.The case outcome was recovered.Relevant history: allergy: allergic to some laundry soap; drug allergies: allergic to lots of medications.Concomitant product(s): none reported.Other product used previously: yes, had used always infinity pads and broke out in genital rash.Exact product used previously: yes.No further information was provided.
 
Manufacturer Narrative
Return of product has been requested.A lot number was provided by the reporter.Full evaluation will occur upon receipt of returned product.This case was initially submitted on 07-aug-2017 with a duplicate mfr.Report #.Please see the correct initial submission: 8022168-2017-00003.
 
Event Description
Bladder infection [cystitis].Urinary tract infection [urinary tract infection].Urinating blood [haematuria].Allergic to the pads [hypersensitivity].Spotted red rash all over private area-female genital [genital rash].Burning sensation all over private area-female genital [genital burning sensation].Itching all over private area-female genital [pruritus genital].Rash in pad area [medical device site rash].Burning sensation in pad area [medical device site paraesthesia].Itching in pad area [medical device site pruritus].Allergic broke out from pads [medical device site hypersensitivity].Case description: a (b)(6) year old female consumer reported via phone on 12-may-2017 that she used always pads ultra thin ultra base version wing long non deodorant 1 pad, 4 times a day ending two and half weeks ago on (b)(6) 2017 and she was allergic to them.She clarified that she initially experienced a red spotted rash in the area of the pad (genital/private area), had a burning sensation, and itching.She asserted that on the third day of experiencing the rash, she started urinating blood, called her physician, who advised her to go to the emergency room.According to the consumer, she was admitted to the hospital for four days with a bladder infection and urinary tract infection.Treatment consisted of antibiotics intravenously while in the hospital.Also, she had to go back to the hospital for intravenous antibiotics as an outpatient afterwards.Product use was discontinued.The case outcome was recovered.Relevant history: allergy: allergic to some laundry soap; drug allergies: allergic to lots of medications.Concomitant product(s): none reported.Other product used previously: yes, had used always infinity pads and broke out in genital rash.Exact product used previously: yes.No further information was provided.07-jul-2017 received product investigation results: manufactured as intended based on investigation: the production lot code 61837786401830283 entered at intake is not a complete or correct lot code.From the production records the lot code should be 6183478600381830283.The consumer has not returned samples to be evaluated.Retains were reviewed and no visible defects were found.The investigation results indicate that the subject product was manufactured as intended.No definitive root cause for the reported issue could be determined; however no plant cause was identified.No further investigation can be performed at this time.Quality assurance will continue to monitor this complaint code for signals and trends as part of the surveillance program of post market product complaint data.
 
Manufacturer Narrative
Return of product has been requested.A lot number was provided by the reporter.Full evaluation will occur upon receipt of returned product.
 
Event Description
Bladder infection [cystitis].Urinary tract infection [urinary tract infection].Urinating blood [haematuria].Allergic to the pads [hypersensitivity].Spotted red rash all over private area-female genital [genital rash].Burning sensation all over private area-female genital [genital burning sensation].Itching all over private area-female genital [pruritus genital].Rash in pad area [medical device site rash].Burning sensation in pad area [medical device site paraesthesia].Itching in pad area [medical device site pruritus].Allergic broke out from pads [medical device site hypersensitivity].Case description: a (b)(6) female consumer reported via phone on (b)(6) 2017 that she used always pads ultra thin ultra base version wing long non deodorant 1 pad, 4 times a day ending two and half weeks ago on (b)(6) 2017 and she was allergic to them.She clarified that she initially experienced a red spotted rash in the area of the pad (genital/private area), had a burning sensation, and itching.She asserted that on the third day of experiencing the rash, she started urinating blood, called her physician, who advised her to go to the emergency room.According to the consumer, she was admitted to the hospital for four days with a bladder infection and urinary tract infection.Treatment consisted of antibiotics intravenously while in the hospital.Also, she had to go back to the hospital for intravenous antibiotics as an outpatient afterwards.Product use was discontinued.The case outcome was recovered.Relevant history: allergy: allergic to some laundry soap; drug allergies: allergic to lots of medications.Concomitant product(s): none reported.Other product used previously: yes, had used always infinity pads and broke out in genital rash.Exact product used previously: yes.No further information was provided.07-jul-2017 received product investigation results: (conclusion code) manufactured as intended based on investigation: the production lot code 61837786401830283 entered at intake is not a complete or correct lot code.From the production records the lot code should be 6183478600381830283.The consumer has not returned samples to be evaluated.Retains were reviewed and no visible defects were found.The investigation results indicate that the subject product was manufactured as intended.No definitive root cause for the reported issue could be determined; however no plant cause was identified.No further investigation can be performed at this time.Quality assurance will continue to monitor this complaint code for signals and trends as part of the surveillance program of post market product complaint data.
 
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Brand Name
ALWAYSPADSULTRATHINULTRABASEVERWINGLONGNONDO
Type of Device
PAD, MENSTRUAL, UNSCENTED
Manufacturer (Section D)
PROCTER & GAMBLE INC
365 university ave
belleville, on K8N5E 9
CA  K8N5E9
Manufacturer (Section G)
PROCTER & GAMBLE INC
365 university ave
belleville, on K8N5E 9
CA   K8N5E9
Manufacturer Contact
regulatory feminine care
6110 center hill avenue
cincinnati, OH 45224
MDR Report Key6770131
MDR Text Key81919607
Report Number8022168-2017-00001
Device Sequence Number1
Product Code HHD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 05/12/2017
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 Operator Lay User/Patient
Device Lot Number61837786401830283
Other Device ID NumberNOT AVAILABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/12/2017
Initial Date FDA Received08/07/2017
Supplement Dates Manufacturer Received07/07/2017
07/07/2017
Supplement Dates FDA Received08/23/2017
09/06/2017
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 Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age54 YR
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