MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-24 for TAMPAXTAMPONSPEARLSUPERNONDO96CT manufactured by Tambrands Manufacturing, Inc.
[184717304]
There is insufficient information to perform a product investigation.
Patient Sequence No: 1, Text Type: N, H10
[184717305]
Consumer contacted via phone and stated that she used a tampon and the string was backwards. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219109-2020-00033 |
| MDR Report Key | 9873820 |
| Report Source | CONSUMER |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-24 |
| 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 | WINTON HILL BUSINESS CENTER B6280 CENTER HILL AVENUE |
| Manufacturer City | CINCINNATI, OH |
| Manufacturer Country | US |
| Manufacturer G1 | TAMBRANDS MANUFACTURING, INC |
| Manufacturer Street | 2879 HOTEL ROAD |
| Manufacturer City | AUBURN, ME |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAMPAXTAMPONSPEARLSUPERNONDO96CT |
| Generic Name | TAMPON, MENSTRUAL, UNSCENTED |
| Product Code | HEB |
| Date Received | 2020-03-24 |
| Lot Number | 91889889 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |