MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-03-21 for TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN manufactured by Tambrands Manufacturing, Inc.
[70484058]
Product and lot number not provided by the reporter, therefore unable to proceed with product investigation at this time.
Patient Sequence No: 1, Text Type: N, H10
[70484059]
Septicemia [sepsis]. Case description: a mother reported via e-mail on (b)(6) 2017 that her (b)(6) daughter used tampax tampon, version/absorbency/scent unknown beginning on an unspecified date, and had septicemia beginning on an unspecified date. She stated that fortunately it was detected a few minutes before her heart was affected. Her daughter was in the hospital for 10 days, and half of that time was on resuscitation. She reported her daughter came out of it. The case outcome was recovered. Concomitant products: none reported. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219109-2017-00002 |
| MDR Report Key | 6421723 |
| Report Source | FOREIGN |
| Date Received | 2017-03-21 |
| Date of Report | 2017-02-20 |
| Date Mfgr Received | 2017-02-20 |
| Date Added to Maude | 2017-03-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY FEMININE CARE |
| Manufacturer Street | 6110 CENTER HILL AVENUE |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | TAMBRANDS MANUFACTURING, INC |
| Manufacturer Street | 2879 HOTEL ROAD |
| 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 UNKNOWN |
| Generic Name | TAMPON, MENSTRUAL, SCENTED |
| Product Code | HIL |
| Date Received | 2017-03-21 |
| Lot Number | NOT AVAILABLE |
| ID Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAMBRANDS MANUFACTURING, INC |
| Manufacturer Address | 2879 HOTEL ROAD AUBURN ME 04210 US 04210 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2017-03-21 |