MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-23 for U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB SUPER PLUS manufactured by Kimberly-clark Corporation - Conway Mill.
[184467185]
Review of the device history record (dhr) and supporting quality records confirmed no anomalies that may have caused or contributed to the malfunction.
Patient Sequence No: 1, Text Type: N, H10
[184467186]
Consumer reported after wearing a tampon for two hours, upon removal the tampon fell apart leaving pieces inside. She was able to manually remove the remaining tampon pieces and did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2381757-2020-00337 |
| MDR Report Key | 9865414 |
| Report Source | CONSUMER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-03-23 |
| 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 | MRS. EMILY ARNOULD, RN BSN |
| Manufacturer Street | 2100 WINCHESTER RD |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207213128 |
| Manufacturer G1 | KIMBERLY-CLARK CORPORATION - CONWAY MILL |
| Manufacturer Street | 480 EXCHANGE AVE. |
| Manufacturer City | CONWAY AR 720327191 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 720327191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB |
| Generic Name | TAMPON, MENSTRUAL, UNSCENTED |
| Product Code | HEB |
| Date Received | 2020-03-23 |
| Model Number | SUPER PLUS |
| Lot Number | AC923122X0112 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORPORATION - CONWAY MILL |
| Manufacturer Address | 480 EXCHANGE AVE. CONWAY AR 720327191 US 720327191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |