MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-12-16 for TAMPAX TAMPON SUPER, VERSION/SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1APPLIC manufactured by Tambrands Manufacturing, Inc..
[1391298]
Multisystem organ failure [multi-organ failure]. Toxic shock [toxic shock syndrome]. Disseminated intravascular coagulation [disseminated intravascular coagulation]. Septic shock [septic shock]. Liver failure [heptic failure]. Lung failure [respiratory failure]. Retained tampon (allowed tampon to remain, not removed in 2006) [foreign body trauma]. Ill [malaise]. Fever [ pyrexia]. Nausea [nausea]. Vomiting [vomiting]. Abdominal pain [abdominal pain]. Diarrhea [diarrhoea]. Septic infection [bacterial infection]. Case description: an attorney reported that his client's daughter, age unspecified, experienced disseminated intravascular coagulation and multisystem organ failure, including liver and lungs, while being hospitalized for treatment of symptoms that developed while on her menstrual period. His client's daughter was using a tampax super tampon. She presented to the emergency room when she became ill with complaints of severe abdominal pain, nausea, frequent vomiting, and diarrhea on event date at 14:14. She was admitted to the hospital the same day at 21:00, and her condition deteriorated including the following: septic infection, toxic shock, septic shock, and bacterial colonization when hospital staff allowed a tampon to remain in place. The tampon was removed two days later. The case outcome was fatal two days later. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[8506507]
Product and lot number not provided by the reporter, therefore, unable to proceed with batch retain testing or product investigation. Reason that the device has not been evaluated by the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2009-00013 |
| MDR Report Key | 1561319 |
| Report Source | 99 |
| Date Received | 2009-12-16 |
| Date of Report | 2009-11-23 |
| Date of Event | 2006-11-04 |
| Date Mfgr Received | 2009-11-23 |
| Date Added to Maude | 2009-12-22 |
| 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 TAMPON SUPER, VERSION/SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1APPLIC |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2009-12-16 |
| 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. Death; 2. Hospitalization | 2009-12-16 |