MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for CARE FREE ORIGINAL UNSCENTED LINERS 49CT manufactured by Playtex Manufacturing, Inc..
[128860665]
A (b)(6) year old female consumer reported that beginning in (b)(6) 2018, each time she would have her period she would notice an irritation in her perineal area that was very painful. She stated that she started changing things but only used panty liners during menstruation, had used them for years and did not change brands. She went to her doctor and was prescribed antibiotics and stated that nothing would help. She purchased an anti-itch cream to treat the reactions that she stated occurred four times. Consumer stated that she went to her physician's office twice before being admitted to the hospital on (b)(6) 2018. She reported that she was tested for sexually transmitted diseases (stds) and a complete blood count (cbc) was done and all results were negative. She stated that she was then diagnosed with a cellulitis skin infection from the open sores. During the hospitalization she was treated with numerous antibiotics and steroids: vancomycin, ketoconazole, clotrimazole, amitriptyline, triamcinolone, doxycycline and hydroxyzine for itching. The consumer reported that she was in the hospital for four nights and was discharged from the hospital over the memorial day holiday weekend (exact date not provided). The consumer reported that she was healing and a follow up visit was scheduled for (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515444-2018-00004 |
| MDR Report Key | 8115766 |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-11-12 |
| Date Added to Maude | 2018-11-29 |
| 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 | MS. JANET GONZALEZ |
| Manufacturer Street | 75 COMMERCE DRIVE |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017858047 |
| Manufacturer G1 | PLAYTEX MANUFACTURING, INC. |
| Manufacturer Street | 804 WALKER DRIVE |
| Manufacturer City | DOVER DE 19904 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19904 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARE FREE ORIGINAL UNSCENTED LINERS 49CT |
| Generic Name | A170448 |
| Product Code | HHD |
| Date Received | 2018-11-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLAYTEX MANUFACTURING, INC. |
| Manufacturer Address | 804 WALKER ROAD DOVER DE 19904 US 19904 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-11-29 |