MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-04-25 for TAMPON (SCENTED/DEODORIZED) SCENTED PLASTIC NA manufactured by First Quality Hygienic, Inc..
[2747603]
The pt used a tampon and when she was ready to remove it she was unable to find the tampon or the withdrawal cord. The pt called her gynecologist to consult about the problem over the phone, and when the tampon could not be located, the gynecologist stated the tampon was probably no longer in the pt's vagina. After eight days, the tampon discharged on its own while the pt was taking a shower. The pt reported the cord was still on the tampon, and that the tampon appeared to have not expanded and was covered with mold. The pt went to the doctor at (b)(6) because she had fever and abdominal pain. The doctor also noted a discolored discharge and prescribed metronidazole (2x daily for one week). No further medical intervention was noted and records were not volunteered by the pt.
Patient Sequence No: 1, Text Type: D, B5
[9817601]
Eval comments: the device history records for associated production lots were reviewed and found to comply with approved sampling, testing, and acceptance activities. Retained samples were examined to confirm withdrawal cords were present and visible and cut to the proper length, and all samples were within specifications. All samples also absorbed syngyna test fluid and expanded as expected. One unused sample was returned by the pt from the same box as she had originally purchased. This sample had no visual defects, the withdrawal cord was present and met specifications, and the tampon absorb and expanded as expected. A search of the complaint database revealed no other complaints associated with this lot having been reported. We cannot confirm that a mfg or other quality defect occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2529605-2012-00002 |
| MDR Report Key | 2553101 |
| Report Source | 04 |
| Date Received | 2012-04-25 |
| Date of Report | 2012-03-26 |
| Date of Event | 2012-03-19 |
| Date Mfgr Received | 2012-03-25 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2012-05-01 |
| 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 | MARK LOEWEN |
| Manufacturer Street | NORTH RD CLINTON COUNTY INDUSTRIAL PARK |
| Manufacturer City | MCELHATTAN PA 17748 |
| Manufacturer Country | US |
| Manufacturer Postal | 17748 |
| Manufacturer Phone | 5707694841 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAMPON (SCENTED/DEODORIZED) |
| Generic Name | VAGINAL TAMPON |
| Product Code | HIL |
| Date Received | 2012-04-25 |
| Model Number | SCENTED PLASTIC |
| Catalog Number | NA |
| Lot Number | 11DRC28B |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FIRST QUALITY HYGIENIC, INC. |
| Manufacturer Address | MCELHATTAN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-25 |