MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-25 for U BY KOTEX SECURITY : TAMPON, MENSTRUAL, UNSCENTED : HEB SUPER manufactured by Kimberly-clark Corporation - Conway Mill.
[188397968]
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
[188397969]
Consumer reported the strings were missing from all the tampons in a 50 count box. She did not use them and discarded all of the tampons.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2381757-2020-00338 |
| MDR Report Key | 9879002 |
| Report Source | CONSUMER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-06-15 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Model Number | SUPER |
| Lot Number | AC916622X0558 |
| 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 | 2020-03-25 |