MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-09-01 for TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK (NOT APPLICABLE) TAMPON 1APPLIC manufactured by Tambrands Manufacturing, Inc..
[1590593]
Tss syndrome [toxic shock syndrome]. High fever [pyrexia]. Temperature about 40 [body temperature increased]. Low blood pressure [hypotension]. Heart rhythm disorder[arrhythmia]. Disturbed heart rate [heart rate abnormal]. Fainting [syncope]. Feeling faint [dizziness]. Swollen joints [joint swelling]. Muscle pains [myalgia]. Diarrhoea [diarrhoea]. Rash on lower legs [rash]. Bottom legs - skin irritation [skin irritation]. Skin is peeling/fingers, toes and soles of feet peeling [skin exfoliation]. Problems with her fingers [unevaluable event]. Case description: a male consumer reported that his daughter, a female consumer of unknown age, used tampax tampon, version/absorbency/scent unknown, number and frequency of applications unknown, on unspecified date(s) and experienced toxic shock syndrome. He reported that his daughter was hospitalised in intensive care for three days. Medical history: no information was provided. Concomitant medication: no information was provided. The outcome of the case was: unknown. No further information was provided. On (b)(6) 2010 a follow-up call was received from the initial reporter, the consumer's father. He reported that his daughter, aged (b)(6), used tampax tampon, version/absorbency/scent unknown, number and frequency of applications unknown, on unspecified date(s): on an unspecified date in (b)(6) 2010, she experienced toxic shock syndrome three to four days after the last application of the product. The consumer additionally experienced a high fever, with a temperature of over 40 degrees for three days, low blood pressure, heart rhythm disorder, heart rate disorder, fainting, feeling faint, joint swelling, muscle pain, diarrhoea, rash and skin irritation of the lower legs and skin peeling on the fingers, toes and soles of her feet. Initially, the consumer was seen by four doctors before her toxic shock syndrome was diagnosed. The consumer was hospitalised on (b)(6) 2010 through (b)(6) 2010; she spent two and a half days in intensive care. No details of treatment received were provided. Medical history: no information was provided. Concomitant medication: no information was provided. The outcome of the case was: unknown. No further information was provided. On (b)(6) 2010 a further follow-up call was received from the initial reporter. He stated that his daughter additionally experienced "problems with her fingers" (unevaluable event) where the skin had peeled off. It was reported that she was on very strong antibiotics. Medical history: no information was provided. Concomitant medication: no information was provided. The outcome of the case was: unknown. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[8763618]
Lot number was not provided by consumer, therefore, unable to proceed with product investigation. Procter & 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 manufactured 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2010-00004 |
| MDR Report Key | 1828151 |
| Report Source | 01 |
| Date Received | 2010-09-01 |
| Date of Report | 2010-08-06 |
| Date of Event | 2010-07-01 |
| Date Mfgr Received | 2010-08-06 |
| Date Added to Maude | 2010-09-10 |
| 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 | 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 TAMPON, VERSION/ABSORBENCY/SCENT UNK (NOT APPLICABLE) TAMPON 1APPLIC |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2010-09-01 |
| 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. Life Threatening | 2010-09-01 |