MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-30 for TAMPAX PEARL TAMPON, REGULAR SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1APPLIC manufactured by Tambrands Manufacturing, Inc..
[2380567]
Toxic shock syndrome - streptococcal toxic shock syndrome [toxic shock syndrome streptococcal]. Lost half a foot and four fingers [injury]. Ards - acute respiratory distress syndrome [acute respiratory distress syndrome]. Lungs spongy, breathing issues [lung disorder]. Ended up popping my lungs - pneumothorax [pneumothorax]. Petechial lesions of hands and feet [petechiae]. Sloughing of hands and feet [skin exfoliation]. Severe vomiting [vomiting]. Nausea unable to eat for three days could not keep anything down [nausea]. Diarrhea [diarrhoea]. Hands and feet hurt, limbs ached [pain in extremity]. Hands and feet - limbs turned blue [cyanosis]. Spike temp 103 and upwards 103. 7 - fever [pyrexia]. Case description: a consumer reported that they, a female age unspecified, used the tampax tampon, version/absorbancy/scent unk, unspecified total daily use, and was admitted to the hosp with toxic shock syndrome. She reported that she had lost half of her foot and four half fingers. Treatment: spent 5 weeks in the icu. The case outcome was not recovered/not resolved. No further info was provided. On (b)(6) 2011 safety f/u phone call to consumer: the consumer, now (b)(6), reported that she was using the tampax pearl tampon, regular scent unk during the day, changing every 4 hrs if a heavy flow, and as her cycle tapered off, changing every 8 hrs; she used a pad for evening and at night, just as she has done all of her life, since her first menstruation. But in (b)(6) 2010, on the 3rd or 4th day of her period, she developed nausea and severe vomiting and after 36 hrs, she went to the er where the doctor felt like the symptoms were due to flu. She went to the er for a second time and the doctor refused to treat her even though she had very clear (unspecified) symptoms of major infection. She hadn't eaten for 3 days because she couldn't keep anything down and on that third day her hands and feet had petechial lesions and they hurt. Her limbs just ached and her husband would rub them to make them feel better but they eventually turned completely blue. She went to the er for a third time and was admitted to the hosp on (b)(6) 2010. On (b)(6) she was iced down when her fever spiked to 103. 7 and she was near death. While hospitalized she developed acute respiratory distress syndrome that made her lungs all spongy and she ended up popping her lungs and now has breathing issues. She was released from the hosp on (b)(6) 2010 and her experience of streptococcal b toxic shock syndrome has been verified by her infectious disease doctor. She experienced sloughing of her hands and feet and, at this time, she has been adjusting to the loss of half her foot and four of her fingers, and to the prosthetics. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[9514182]
Lot number was not provided by consumer and product not received to date therefore unable to proceed with product investigation. Proctor & gamble (p&g) is submitting this report only because it believes an event that meets the requirements of 21 cfr part 803 may have occurred. This does not mean that p&g believes the device mfg by p&g may be defective or has malfunctioned, or that a tampax product was in fact associated with an actual consumer injury. Consequently, this report must not be construed as an admission of any kind by p&g.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2011-00008 |
| MDR Report Key | 2236741 |
| Report Source | 04 |
| Date Received | 2011-08-30 |
| Date of Report | 2011-08-01 |
| Date Mfgr Received | 2011-08-01 |
| Date Added to Maude | 2011-09-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 6110 CENTER HILL AVE. WINTON HILL BUSINESS CTR |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | TAMBRANDS MANUFACTURING, INC. |
| Manufacturer Street | 2879 HOTEL RD. |
| Manufacturer City | AUBURN ME 04210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 04210 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAMPAX PEARL TAMPON, REGULAR SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1APPLIC |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2011-08-30 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAMBRANDS MANUFACTURING, INC. |
| Manufacturer Address | AUBURN ME US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2011-08-30 |