MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-01-03 for STAYFREE ULTRA THIN MAXI WINGS manufactured by Johnson & Johnson, Inc..
[1776355]
Consumer placed product into underwear in anticipation of her menstruation, within a few mins, she began to experience a burning sensation. Product was discontinued, she saw her doctor who confirmed irritation and prescribed cortisone cream. The irritation worsened and the wound was described and required approx 18 stitches.
Patient Sequence No: 1, Text Type: D, B5
[8925474]
Date of this submission is (b)(4) 2011. This closes out this report unless additional significant info is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022269-2011-00001 |
| MDR Report Key | 1956585 |
| Report Source | 04 |
| Date Received | 2011-01-03 |
| Date of Report | 2010-12-05 |
| Date of Event | 2010-12-03 |
| Date Mfgr Received | 2010-12-05 |
| Date Added to Maude | 2011-01-14 |
| 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 | BRAD LAMOTTE |
| Manufacturer Street | 185 TABOR RD |
| Manufacturer City | MORRIS PLAINS NJ 07950 |
| Manufacturer Country | US |
| Manufacturer Postal | 07950 |
| Manufacturer Phone | 9733853667 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAYFREE ULTRA THIN MAXI WINGS |
| Generic Name | NONE |
| Product Code | HHD |
| Date Received | 2011-01-03 |
| Lot Number | 3169M6337 |
| Operator | LAY USER/PATIENT |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON, INC. |
| Manufacturer Address | 7101 RUE NOTRE-DAME E MONTREAL, QUEBEC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-03 |