MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-10-30 for ALWAYS MAXI PAD WITH FLEXI-WINGS, OVERNIGHT EXTRA HEAVY (NOT manufactured by Knh Enterprise Co. Ltd.
[1394609]
(provisional diagnosis) chemical burn/exposure between legs-skin [chemical burn of skin]. Perianal dermatitis [dermatitis]. Blistered skin, little fine blisters [blister]. Oozing, weeping-skin from vaginal area to buttocks [secretion discharge]. Irritated, raw skin [skin irritation]. Huge welt [urticaria]. Tiny pustules [rash pustular]. Eaten top layer of skin off [skin injury]. Wound [wound]. Skin rash from vaginal area up to buttocks [rash]. Eaten the skin completely to white [skin discoloration]. Skin peeled [skin exfoliation]. Skin breakdown [skin disorder]. Case description: a consumer reported that her daughter used the always maxi pad with flexi-wings, overnight extra heavy unscented pad during her menstrual cycle in 2009, and developed perianal dermatitis so bad that she had to be hospitalized for two days. Her symptoms included: blistered skin, little fine blisters, a skin rash from the vaginal area up to buttocks, oozing, weeping skin from vaginal area to buttocks, and irritated, raw skin. She was taken to the emergency room and admitted to the hospital, where every type of bacterial test result came back negative. Treatment included an unspecified antibiotic ointment cream. She was released from the hospital, the perianal dermatitis resolved, and the symptoms were clearing up. She was using the always maxi pads again for her late sep menstrual cycle, when the same area of her skin was starting to rise a little bit three weeks later. She kept the are clean, but after wearing a pad overnight she awoke with little fine blisters the following day. The case outcome was not recovered/not resolved. Past medical history included: allergy - none reported. Concomitant medications included: immunosuppressants and anti inflammatory agents to treat rheumatoid arthritis. No further info was provided. In the same month, safety follow-up phone call to consumer: the customer reported that her daughter was hospitalized on event date, the day the symptoms first appeared. Additional symptoms included: a huge welt, tiny pustules, wound, provisional diagnosis of chemical burn/exposure between legs, and the reaction had "eaten the top layer of skin off". Her daughter was admitted into isolation in the emergency dept in case she had a "flesh eating bacteria". Additional treatment included: morphine for pain control, an unspecified thick proactive cream, and discontinuation of product use. Labs included blood tests, which were negative and wound cultures, which were negative. She was discharged from the hospital two days later, and visited her family physician for follow-up right away, because she was still raw. New skin was forming, when her daughter used an always overnight maxi fresh scent pad, for 45 minutes in later sept, and developed a second reaction of little pustules that wore away the new layer of skin. Health care professionals consulted, included her pediatrician and a dermatologist by phone, gynecological and infectious disease consultants while in the hospital. The case outcome was improved. She had been using always during menses for the past four months. No further info was provided. On 20-sep-2009, update: details revealed in a review of the initial contact of the same day: the consumer reported that her daughter experienced additional symptoms of a skin breakdown, and the area between her legs hurt and was sore. The area had been clearing up for 4 or 5 days after she was discharged from the hospital, but was not completely healed when menses returned and she applied the always maxi pad with flexi-wings, overnight extra unscented pad twenty six days after the event. Some of the symptoms began to recur. No further info was provided. On 20-oct-2009: lot check results received: requested product samples from the consumer on 05-oct-2009, but have not received the product to date. A lot check on 07-oct-2009, for 0107139194528712, revealed no other complaints with this lot number. The product lot number was clarified as 0907139194528712 following the review of the customer's initial call, and the lot check on 20-oct-2009, revealed no other complaints with this lot number. A batch retain was requested, and the results are pending.
Patient Sequence No: 1, Text Type: D, B5
[8321697]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004176863-2009-00001 |
| MDR Report Key | 1543328 |
| Report Source | 04 |
| Date Received | 2009-10-30 |
| Date of Report | 2009-09-30 |
| Date of Event | 2009-09-02 |
| Date Mfgr Received | 2009-09-30 |
| Date Added to Maude | 2009-11-27 |
| 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 | 3 |
| 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 | KNH ENTERPRISE CO. LTD. |
| Manufacturer Street | NO. 66-1 SANJI, SANJI VILLAGE JIANGIYN TOWNSH |
| Manufacturer City | TAINAN COU, TAIWAN 72548 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 72548 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYS MAXI PAD WITH FLEXI-WINGS, OVERNIGHT EXTRA HEAVY (NOT |
| Generic Name | NONE |
| Product Code | HHD |
| Date Received | 2009-10-30 |
| Lot Number | 0907139194528712 |
| 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 | KNH ENTERPRISE CO. LTD |
| Manufacturer Address | SANJI VILLAGE, JIANGIYN TOWNSH TAINAN COU TAIWAN TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2009-10-30 |