MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-05 for TAMPAX PEARL TAMPON, ABSORBENCY/SCENT UNK (NA) TAMPON 1 APPLIC manufactured by Tambrands Manufacturing, Inc..
[1644996]
Toxic shock syndrome [toxic shock syndrome], total organ failure [multi-organ failure], subarachnoid bleed [subarachnoid haemorrhage], mycotic aneurysm [mycotic aneurysm], bruise on thigh [contusion], nausea [nausea], vomiting [vomiting], muscle aches [myalgia], headache [headache], fever of 103 [pyrexia], did not have elevated white blood count but did have bands present [band neutrophil count], infective endocarditis, staphylococcal endocarditis [endocarditis staphylococcal], echocardiogram showed vegetative growth on mitral valve [echocardiogram abnormal], hemoptysis [haemoptysis], platelets dropped from 158 to 27 [platelet count decreased], creatinine is elevated [blood creatinine increased], staph aureus blood cultures all positive, blood cultures were (b) (6). Case description: a physician reported that her pt, an adult female (b) (6), used a tampax pearl tampon, absorbency/scent unk, on (b) (6) 2010, for post coital bleeding and was admitted to the hospital critical care unit on (b) (6) 2010 after developing toxic shock syndrome and ultimately total organ failure. The physician was not sure how long the tampon was left in, but on (b) (6) 2010 her pt developed nausea, vomiting, diarrhea, muscle aches, headache and a fever of 103. She had petechiae on one toe and a bruise on her thigh. She presented to the emergency dept and was subsequently admitted to the hospital with her fever gone but other symptoms still present. She did not have an elevated white blood count, but did have bands present. At first she was thought to have meningitis, but her lumbar puncture was clear. Within two hours during the evening of (b) (6) 2010, her pt developed total organ failure. She had infective endocarditis (echocardiogram showed vegetative growth on her mitral valve), hemoptysis, platelets dropped from 158 to 27, her creatinine was elevated. Since the one week she has been hospitalized, she has had a mycotic aneurysm and subarachnoid bleed. Six cultures came back positive for strep. The physician felt as if the pt was going to die. The case outcome was not recovered/not resolved. No further info was provided. On (b) (6) 2010, external medical consultant f/u phone call to reporting physician: the physician reported that the blood cultures were all positive for staph aureus, not strep. Her pt has staphylococcal endocarditis. Past medical history included an unspecified gynecological procedure in (b) (6) 2010. No further info was provided. On (b) (6) /2010: safety f/u phone call to reporting physician: the physician reported that her pt's staph went into an infective endocarditis. Six out of six blood cultures were (b) (6). She had a bleed into her head, is on a ventilator, and had a tracheotomy today. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[8539779]
Lot number and product sample not available (not provided) to the physician reporting case info; therefore, unable to proceed with batch retain testing or product investigation. Reason tha the device has not been evaluated by the mfr: tss. Add'l info: (us) otc device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2010-00002 |
| MDR Report Key | 1656524 |
| Report Source | 05 |
| Date Received | 2010-04-05 |
| Date of Report | 2010-03-22 |
| Date Mfgr Received | 2010-03-22 |
| Date Added to Maude | 2010-04-14 |
| 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 Contact | LENORE FAULHABER, PHD, MBA, MGR |
| Manufacturer Street | 6110 CENTER HILL AVE. WINTON 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 (NA) TAMPON 1 APPLIC |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2010-04-05 |
| 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. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2010-04-05 |