MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,04 report with the FDA on 2010-11-12 for TAMPAX TAMPON, VERSION/ABSORBANCY/SCENT UNK manufactured by Tambrands Manufacturing, Inc..
[18961699]
To date, product details including lot number was not provided by reporter therefore unable to proceed with batch retain testing or 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. Reason that the device has not been evaluated by the mfr: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19103652]
Toxic shock [toxic shock syndrome]. In a coma probably a couple of years [coma]. It went through bone marrow [bone marrow disorder]. Case description: a consumer reported that they, a female with age unspecified, used tampax tampon, version/absorbency/scent unk, unspecified total daily use, and was hospitalized for two months after developing toxic shock. She reported that according to the doctors, it went through her bone marrow and she had to have artificial hip and shoulder surgery to treat the symptom; she was also in a coma. The consumer reported that it has been a couple of years and she has visited seven doctors and surgeons who are looking at how she became so sick; there was no cut in her body so they think the toxic shock was from the use of tampons. The case outcome was recovered. Other product used previously: yes - tampons for 8-9 years. No further info was provided. On (b)(6)-2008 received consumer's follow-up phone call: the consumer reported that she was having her period at the time her doctors found that she had no cuts on her body. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219109-2008-00009 |
| MDR Report Key | 1949455 |
| Report Source | 00,01,04 |
| Date Received | 2010-11-12 |
| Date of Report | 2010-11-12 |
| Date Mfgr Received | 2008-04-15 |
| Date Added to Maude | 2011-03-30 |
| 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 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/ABSORBANCY/SCENT UNK |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2010-11-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Other; 2. Required No Informationntervention | 2010-11-12 |