MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-11-20 for STAYFREE ULTRA THIN OVERNIGHT manufactured by Johnson & Johnson, Inc..
[985404]
Consumer reported when she applied pad to panties her internal vaginal area, rectum and both inner part of thighs became very swollen and red. She reported that she experienced rectum discharge, pain in both arms and trouble breathing. Symptoms were still present at the time of her report. Consumer contacted her healthcare professional and received treatment of fexofenadine and fluticasone. Consumer contacted her healthcare professional and received treatment of fexofenadine and fluticasone. Consumer went to the er. Request for medical records has been sent.
Patient Sequence No: 1, Text Type: D, B5
[8135935]
Complaint trend monitored. This report is considered closed unless additional relevant info is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022269-2008-00004 |
| MDR Report Key | 1241774 |
| Report Source | 04 |
| Date Received | 2008-11-20 |
| Date of Report | 2008-11-19 |
| Date of Event | 2008-11-07 |
| Date Mfgr Received | 2008-11-07 |
| Date Added to Maude | 2009-01-22 |
| 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 | ANGELINA HUNT |
| Manufacturer Street | 199 GRANDVIEW ROAD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9088742943 |
| Manufacturer G1 | JOHNSON & JOHNSON, INC. |
| Manufacturer Street | 7101 NOTRE DAME ST. EAST |
| Manufacturer City | MONTREAL H1N2G4 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | H1N 2G4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAYFREE ULTRA THIN OVERNIGHT |
| Generic Name | PAD, MENSTRUAL, SCENTED-DEODORIZED |
| Product Code | NRC |
| Date Received | 2008-11-20 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON, INC. |
| Manufacturer Address | MONTREAL H1N2G4 CA H1N 2G4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2008-11-20 |