MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-11-30 for TAMPAX PEARL TAMPON, ABSORBENCY/SCENT UNK TAMPN 1 APPLIC manufactured by Tambrands Manufacturing, Inc..
[17375671]
Toxic shock syndrome (provisional diagnosis) [toxic shock syndrome]. Fever 102 f to 105 f [pyrexia]. Dizziness upon standing [dizziness postural]. Rash in chest area, went to entire body, but more prominent in legs and arms [rash generalised]. Palms of hands bright red [palmer erythema]. Diarrhea/loose stools [diarrhoea]. Itching in chest area, went to entire body, but more prominent in legs and arms [pruritus generalised]. Swelling more prominent on arms on legs [oedema peripheral]. Muscle ache [myalgia]. Swollen tongue [swollen tongue]. Tongue red [tongue disorder]. Whole body looks puffy [generalised oedema]. Bottom of feet bright red [planter erythema]. Headache [headache]. Weakness [asthenia]. Hands peeling now [skin exfoliation]. Case description: a consumer reported that her daughter used tampax pearl tampon, absorbency/scent unk in 2009 and was hospitalized for five days, three of the days in the intensive care unit with toxic shock syndrome (provisional diagnosis). She developed symptoms of fever 102 f, headache, dizziness upon standing, muscle aches, diarrhea, loose stools, swelling more prominent in legs and arms, palms of hands and bottom of feet became bright red, a skin rash that looked like burning and itching that started in the chest area and eventually went to entire body, but more prominent in legs and arms. The symptoms started to appear the following day. She visited a hospital when her fever reached 105 f two days later, then was sent to the emergency room and admitted to the intensive care unit the following day. Her whole body looked puffy and her tongue was very red and swollen. Treatment: 4 unspecified antibiotics while hospitalized (discharged with 2 of the antibiotics), "all kinds of fluids and electrolytes through iv", potassium, sodium, medications to control blood pressure, and medications for rash/itching. Her symptoms completely disappeared three days later, and she was discharged from the hospital the following day. The case outcome was resolved. Past medical history included: allergy - none reported. Concomitant medications included: oral contraceptive. No further info was provided. The following month safety follow-up phone call to consumer. The consumer reported that her daughter had experienced an additional symptom of weakness on event date. She was initially treated for influenza and then started on antibiotics. Her daughter's hands were peeling now. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[17666341]
Requested product samples from consumer on 09-nov-2009. The consumer has not returned product samples to date. A lot number was not provided by the reporter therefore, unable to proceed with a lot check and batch retain testing at this time. Reason that the device has not been evaluated by the mfr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2009-00012 |
| MDR Report Key | 1549511 |
| Report Source | 04 |
| Date Received | 2009-11-30 |
| Date of Report | 2009-11-02 |
| Date of Event | 2009-10-23 |
| Date Mfgr Received | 2009-11-02 |
| Date Added to Maude | 2009-12-04 |
| 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 BUSINESS CTR 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 PEARL TAMPON, ABSORBENCY/SCENT UNK TAMPN 1 APPLIC |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2009-11-30 |
| 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. Required No Informationntervention | 2009-11-30 |