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 2013-03-08 for TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK manufactured by Tambrands Manufacturing, Inc..
[3385422]
Septicemia [sepsis]. E. Coli in blood stream [escherichia bacteraemia]. Stopped blood from clotting [coagulopathy]. (e. Coli in blood stream) attacking liver [liver injury]. Fallopian tube developed a cyst [fallopian tube cyst]. Temperature of 39. 5 (103. 1 f) [pyrexia]. Pus and fluid-fallopian tube [purulence]. Retained tampon [foreign body]. Had rigours [chills]. Getting more and more unwell [malaise]. Tampon left in for about a week [device misuse]. Case description: a consumer reported via email that they, a female age unspecified, used tampax tampon, version/absorbency/scent unknown, last known use retained a tampon for one week, (b)(6) 2012 through (b)(6) 2012, and was hospitalized after developing septicemia. She had removed the tampon at 17:00 on (b)(6) 2012 and by 02:00 she had developed chills and a temperature of 39. 5. Her husband called an ambulance and she was taken to the hospital where, after a few hours, a junior doctor from the gynecology department did an internal examination, blood tests, and sent a swap off; in the meantime she was put on a drip to stop her from dehydrating. The consumer lay on a trolley in the emergency department for 10 hours and was slowly getting more unwell. By the time she was transferred to another hospital and admitted to the private wing, she had developed septicaemia, e. Coli was in her blood stream and had started attacking her liver, stopping her blood from clotting; a scan revealed one fallopian tube had developed a cyst, pus and fluid too. Within minutes, a haematologist, gynecologist, and infection specialist were at her bedside administering a strong combination of unspecified antibiotics trying to cure her. The consumer was released from the hospital after almost a week and came home in an emotional state of shock and feeling very depressed about how this could have happened; she felt earlier scans, immediate cultures, and antibiotic intervention would have kept her from becoming so ill. She was finally feeling well enough to report the incident (on (b)(6) 2013). The case outcome was improved. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[10526309]
Lot number or product was not provided by the reporter; unable to proceed with product investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2013-00002 |
| MDR Report Key | 2999894 |
| Report Source | 00,01,04 |
| Date Received | 2013-03-08 |
| Date of Report | 2013-01-30 |
| Date Mfgr Received | 2013-01-30 |
| Date Added to Maude | 2013-03-13 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6110 CTR HILL AVE, WINTON HILL BUS. CTR. CARE |
| 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 |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2013-03-08 |
| 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. Other | 2013-03-08 |