MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-08-21 for PLAYTEX SPORT (UNSCENTED) TAMPONS W/ODORSHIELD manufactured by Playtex Manufacturing, Inc..
[3959018]
On (b)(6), an email was rec'd from the mother of a (b)(6) consumer. The email advised that the daughter was taken by ambulance to the hospital on (b)(6) 2013 after passing out in the shower. The mother said she had flu like symptoms and had to be taken to the hospital by ambulance. While at the hospital her blood pressure dropped to 42/27 and she was immediately transported by ambulance to another children's hospital icu where she was diagnosed with toxic shock syndrome. According to the info in the email, she was on the last day of her period and had used playtex tampons for the past 2 yrs with no problems. Her mother further states she remained in the icu for several days and rec'd iv fluids and antibiotics. Her kidneys were not functioning properly and she developed fluid in her right lung. Her blood pressure remained very low while her heart rate was high. She was released on (b)(6) 2013 with two prescribed medications (doxycycline and cefdinir).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515444-2013-00008 |
| MDR Report Key | 3312753 |
| Report Source | 00 |
| Date Received | 2013-08-21 |
| Date of Report | 2013-08-21 |
| Date of Event | 2013-07-14 |
| Date Mfgr Received | 2013-07-21 |
| Date Added to Maude | 2013-08-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JENNIFER MARTIN REMPE |
| Manufacturer Street | 6 REASEARCH DR. |
| Manufacturer City | SHELTON CT 06484 |
| Manufacturer Country | US |
| Manufacturer Postal | 06484 |
| Manufacturer Phone | 2017858110 |
| Manufacturer G1 | PLAYTEX MANUFACTURING INC. |
| Manufacturer Street | 804 WALKER RD. |
| 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 | 3 |
| Brand Name | PLAYTEX SPORT (UNSCENTED) TAMPONS W/ODORSHIELD |
| Generic Name | PLAYTEX SPORT TAMPON, UNSCENTED, REGULAR |
| Product Code | HIL |
| Date Received | 2013-08-21 |
| 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 | PLAYTEX MANUFACTURING, INC. |
| Manufacturer Address | DOVER DE US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2013-08-21 |