MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-24 for ALWAYSPADSULTRATHINULTRABASEVERWINGLONGNONDO manufactured by Procter & Gamble Inc.
[83541249]
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 (b)(6) 2017 with a duplicate mfr. Report # 8022168-2017-00001. This corrected initial submission, including product investigation, has the actual mfr report #.
Patient Sequence No: 1, Text Type: N, H10
[83541250]
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. On 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022168-2017-00003 |
| MDR Report Key | 6817985 |
| Report Source | CONSUMER |
| Date Received | 2017-08-24 |
| Date of Report | 2017-05-12 |
| Date Mfgr Received | 2017-07-07 |
| Date Added to Maude | 2017-08-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 | 6110 CENTER HILL AVENUE |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | PROCTER & GAMBLE INC |
| Manufacturer Street | 365 UNIVERSITY AVE |
| Manufacturer City | BELLEVILLE, ON K8N5E9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K8N5E9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYSPADSULTRATHINULTRABASEVERWINGLONGNONDO |
| Generic Name | PAD, MENSTRUAL, UNSCENTED |
| Product Code | HHD |
| Date Received | 2017-08-24 |
| Lot Number | 61837786401830283 |
| ID Number | NOT AVAILABLE |
| 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 | 365 UNIVERSITY AVE BELLEVILLE, ON K8N5E9 CA K8N5E9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2017-08-24 |