MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for ALWAYSLNRDAILIESXTRAPRTCREGNONDO50CT manufactured by Procter & Gamble Inc.
[123069176]
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.
Patient Sequence No: 1, Text Type: N, H10
[123069177]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022168-2018-00001 |
| MDR Report Key | 7939055 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-10-08 |
| Date Added to Maude | 2018-10-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY FEMININE CARE |
| Manufacturer Street | WINTON HILL BUSINESS CENTER B6280 CENTER HILL AVENUE |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | PROCTER & GAMBLE INC |
| Manufacturer Street | 355 UNIVERSITY AVE |
| Manufacturer City | BELLEVILLE, ONTARIO K8N5E9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K8N5E9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALWAYSLNRDAILIESXTRAPRTCREGNONDO50CT |
| Generic Name | PAD, MENSTRUAL, UNSCENTED |
| Product Code | HHD |
| Date Received | 2018-10-05 |
| Lot Number | 8156478600 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE INC |
| Manufacturer Address | 355 UNIVERSITY AVE BELLEVILLE, CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-10-05 |