MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-08-19 for ALWAYS MAXI PAD + ODOR LOCK, ABSORBENCY UNK LIGHTLY SCENTED manufactured by Procter & Gamble, Inc..
[16177190]
Physician thinks has third degree chemical burn from chemical in the always pads [chemical burn of skin]. Irritation - female genital [genital discomfort]. Full blown blisters from vagina to back of bottom - genital [vaginal mucosal blistering]. Painful - female genital [genital pain]. Scar - female genital [scar]. Left side of vagina completely numb [genital hypoaesthesia]. Inside anus completely numb [hypoaesthesia]. Case description: a regulatory authority reported that a female, age unspecified, used always maxi pad + odor lock, absorbency unk lightly scented pad and reported the following: third degree burns after using always pads-female genital on (b)(6) 2014. The case outcome was unk. No further info was provided. (b)(6) 2014 received fda maude report: in a manufacturer and user facility device experience report (mw50306007), a female consumer, age unspecified, report that she had used always maxi soft and clean odor lock pads 1 unit, 1 only on (b)(6) 2014 during her period and reported the following: irritation on her bottom about an hour after she applied the pad on (b)(6) 2014. Within days, she reported that she had full blown blisters from her vagina to back of bottom that were the exact pattern of the pad. The area was so painful that she could barely sleep, sit or do household chores. The consumer visited her physician who prescribed aloe vera with lidocaine and silver sulfadiazine cream to ease the pain. She reported that he physician thought she had a third degree chemical burn from a chemical in the always pad. The consumer reported that she had scars and the left side of the vagina and inside the anus was completely numb. The case outcome was improved. Concomitant medications included: sertralin, topiramate. No further info was provided. (b)(6) 2014 received consumer's follow up questionnaire: a (b)(6) female reported that she used (b)(6), 1 only for about three hours on (b)(6) 2014 and reported that her vagina had third degree burns for six weeks from the chemical in the pads. The consumer reported that her blisters had resolved but the area continues to be completely numb. The consumer visited her physician who prescribed silver sulfadiazine cream 1%, aloe vera with lidocaine and an oral steroid. The case outcome was improved. Past medical history included: medical history - migraine, anxiety. Concomitant medications included: sertralin 100 mg, 1/day for anxiety, topiramate 50 mg, 2/day for migraine, xanax 1 mg, as needed for anxiety. Other product used previously without incident : yes - (b)(6) pads. No further info was provided. Product returned (b)(6) 2014. Awaiting product investigation results.
Patient Sequence No: 1, Text Type: D, B5
[16386431]
Product returned 08/06/2014. Investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022168-2014-00002 |
| MDR Report Key | 4058566 |
| Report Source | 00 |
| Date Received | 2014-08-19 |
| Date of Report | 2014-05-19 |
| Date Mfgr Received | 2014-07-30 |
| Date Added to Maude | 2014-09-08 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6110 CENTER HILL AVE WINTON HILL BUSINESS CENTER |
| 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 | 3 |
| Brand Name | ALWAYS MAXI PAD + ODOR LOCK, ABSORBENCY UNK LIGHTLY SCENTED |
| Generic Name | NONE |
| Product Code | NRC |
| Date Received | 2014-08-19 |
| Lot Number | 400947860042 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE, INC. |
| Manufacturer Address | BELLEVILLE, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-19 |