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

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.

• 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 Key: 6770131
• MDR Text Key: 81919607
• Report Number: 8022168-2017-00001
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: 61837786401830283
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 08/07/2017
• Supplement Dates Manufacturer Received: 07/07/2017; 07/07/2017
• Supplement Dates FDA Received: 08/23/2017; 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 Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 54 YR