MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,04 report with the FDA on 2015-06-11 for TAMPAX PEARL TAMPON, REGULAR SCENTED manufactured by Tambrands Manufacturing, Inc.
[5936556]
Toxic shock syndrome [toxic shock syndrome]. Ill [malaise]. Case description: a mother reported that her daughter, age unspecified, used tampax pearl tampon, regular scented on unspecified date, for the first time as the mother had purchased these scented ones by mistake. The mother reported that her daughter was very responsible and never left the tampons in longer than suggested, but that two days into her period, she became very ill. The mother reported that they quickly figured out that it was toxic shock syndrome and that her daughter almost died and was in the intensive care unit for days. The mother reported that this was her daughter's third cycle using tampons. The case outcome was unknown. No further information was reported.
Patient Sequence No: 1, Text Type: D, B5
[32101214]
Toxic shock syndrome [toxic shock syndrome]. Ill [malaise]. Case description: a mother reported that her daughter, age unspecified, used tampax pearl tampon, regular scented on unspecified date, for the first time as the mother had purchased these scented ones by mistake. The mother reported that her daughter was very responsible and never left the tampons in longer than suggested, but that two days into her period, she became very ill. The mother reported that they quickly figured out that it was toxic shock syndrome and that her daughter almost died and was in the intensive care unit for days. The mother reported that this was her daughter's third cycle using tampons. The case outcome was unknown. No further information was reported. (b)(6) 2015 received product investigation results: the lot code provided is valid for the product specified. The product was manufactured on 29-sep-2014 on line (b)(4). There is a corrective action in progress for accidental purchase of scented product in the tampax pearl business. Logbook comments, variable and attribute testing, centerlines, and downtime events for the subject lot were reviewed. There were no deviations or events recorded that would have contributed to the observed defect. There were no provisional material acceptances that relate to this complaint or records of related rejected materials. The production date, one day before and one day after were reviewed and there were no alerts, out of specification, or events reported that could have contributed to the complaint. The results of this evaluation indicate that the product for the subject lot was manufactured as intended. Additionally, it was determined that tampax scented product adequately achieves the design expectations for identifying scented product. However, in response to a complaint signal a request was made to update artwork and increase the prominence of the "fresh scent" call out to better communicate to consumers which product is scented. This artwork began production in spring 2015. The consumer did not return product to confirm the alleged defect at the time of this investigation. If a returned product is received in relation to this complaint the investigation will be re-opened and any new information will be incorporated. Three retain samples from the subject lot were visually inspected and appear to be made as intended. No defects that relate to the described complaint were found. The review of this investigation indicates that the subject product lot was manufactured as intended and no definite root cause could be identified for the adverse event. No further investigation is needed at this time on this complaint. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219109-2015-00004 |
| MDR Report Key | 4838572 |
| Report Source | *,04 |
| Date Received | 2015-06-11 |
| Date of Report | 2015-06-05 |
| Date Mfgr Received | 2015-06-29 |
| Date Added to Maude | 2015-06-11 |
| 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 | 0 |
| Event Location | 0 |
| 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 PEARL TAMPON, REGULAR SCENTED |
| Generic Name | TAMPON, MENSTRUAL, SCENTED |
| Product Code | HIL |
| Date Received | 2015-06-11 |
| Lot Number | 4272243065 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-06-11 |