MAUDE Adverse Event Report: PROCTER & GAMBLE INC ALWAYSLNRDAILIESXTRAPRTCREGNONDO50CT; PAD, MENSTRUAL, UNSCENTED

Lot Number 8156478600

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pneumonia (2011); Urinary Tract Infection (2120); Urinary Frequency (2275)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Return of product has been requested.Lot number was provided and an initial check for quality deviations was performed with none present.An investigation has been initiated using the provided lot code.Full evaluation will occur upon receipt of returned product.

Event Description

Urinary tract infection - urinary tract - recurrent [urinary tract infection].Pneumonia.Pressure - pelvic region [pelvic discomfort].Pain - pelvic region.Urinary frequency - urinary tract [pollakiuria].Burning sensation upon urination - urinary tract [dysuria].Liners used for bladder leaks [device use issue].Case description: a (b)(6) female consumer reported spontaneously via phone on (b)(6) 2018 that she used always liners dailies xtra protection regular non deodorant 50 count beginning on an unspecified date for bladder leaks.The consumer elaborated that she'd been using the liners for a couple of years and she'd had 4 urinary tract infections (utis) since (b)(6) 2018.Per the consumer, her urologist told her last week after she'd had her fourth uti that she should stop wearing the liners at home (it was okay to wear them to go out) as the urine in the liner was sitting against the consumer and causing her utis.The consumer confirmed that she was still using the liners, just not at home; she changed the pads frequently.She noted that she was in the hospital for one week in (b)(6) 2018 with pneumonia and a uti; the current uti the consumer was suffering with was her first one since (b)(6) 2018.Additional adverse events included pressure in the pelvic region, pain in the pelvic region, urinary frequency, and a burning sensation upon urination.She was currently receiving intravenous antibiotics for this current uti; it had been a week that the consumer had been on it, and she reported that things were improving.The consumer had also visited her gynecologist.The overall case outcome was improved.Relevant history: allergy/intolerance - multiple allergies.Concomitant product(s): none reported.No further information was provided.

Event Description

Urinary tract infection - urinary tract - recurrent [urinary tract infection].Pneumonia [pneumonia].Pressure - pelvic region [pelvic discomfort].Pain - pelvic region [pelvic pain].Urinary frequency - urinary tract [pollakiuria].Burning sensation upon urination - urinary tract [dysuria].Liners used for bladder leaks [device use issue].Case description: a 76 year old female consumer reported spontaneously via phone on (b)(6) 2018 that she used always liners dailies xtra protection regular non deodorant 50 count beginning on an unspecified date for bladder leaks.The consumer elaborated that she'd been using the liners for a couple of years and she'd had 4 urinary tract infections (utis) since (b)(6) 2018.Per the consumer, her urologist told her last week after she'd had her fourth uti that she should stop wearing the liners at home (it was okay to wear them to go out) as the urine in the liner was sitting against the consumer and causing her utis.The consumer confirmed that she was still using the liners, just not at home; she changed the pads frequently.She noted that she was in the hospital for one week in (b)(6) 2018 with pneumonia and a uti; the current uti the consumer was suffering with was her first one since (b)(6) 2018.Additional adverse events included pressure in the pelvic region, pain in the pelvic region, urinary frequency, and a burning sensation upon urination.She was currently receiving intravenous antibiotics for this current uti; it had been a week that the consumer had been on it, and she reported that things were improving.The consumer had also visited her gynecologist.The overall case outcome was improved.Relevant history: allergy/intolerance - multiple allergies.Concomitant product(s): none reported.No further information was provided.On 08-oct-2018 received consumer questionnaire: the consumer reported that she used 1 pad 10 times a day, and continued using the product.She used the product for one month before the problem occurred, and had not used this exact product before.She purchased the product on an unspecified date in (b)(6) 2018.Previously, she used always panty liners.Per the consumer's report, her doctor said that using the pads for bladder leakage could cause a uti.She sought medical attention, and treatment that was prescribed/recommended by the healthcare professional included antibiotics and not using the product while at home.She stated that the prescribed/recommended treatment had been followed, but she was waiting for her recheck results and as such it was unknown if her problem had resolved.The case outcome remained improved.Other relevant history: allergy/intolerance - soap, scents.Concomitant product(s): unspecified.No further information was provided.On 02-nov-2018: product investigation results: the investigation has been completed with no manufacturing cause identified.The consumer did not return the device despite multiple requests.

Manufacturer Narrative

On 02-nov-2018: product investigation results: the investigation has been completed with no manufacturing cause identified.The consumer did not return the device despite multiple requests.

• Brand Name: ALWAYSLNRDAILIESXTRAPRTCREGNONDO50CT
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PROCTER & GAMBLE INC; 355 university ave; belleville, ; CA
• MDR Report Key: 7939055
• MDR Text Key: 123069176
• Report Number: 8022168-2018-00001
• 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
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 8156478600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 10/08/2018
• Supplement Dates FDA Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 76 YR
• Patient Weight: 51