MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-10-16 for STAYFREE CLEAN manufactured by Johnson & Johnson, Inc..
[19248285]
Consumer alleged that when she applied the product, she developed second degree burns, contact dermatitis, swelling, pain and redness on external vaginal area. She was treated by her physician with a&d ointment and sitz baths. Symptoms have not abated. No further information was given. This closes this report unless additional significant information is received.
Patient Sequence No: 1, Text Type: D, B5
[19514943]
This event was re-assessed by the medical reviewer and determined to be a reportable event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022269-2007-00011 |
| MDR Report Key | 928364 |
| Report Source | 04 |
| Date Received | 2007-10-16 |
| Date of Report | 2007-10-16 |
| Date of Event | 2007-09-11 |
| Date Mfgr Received | 2007-09-11 |
| Date Added to Maude | 2007-10-22 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAYFREE CLEAN |
| Generic Name | MENSTRUAL PAD PLUS CLEANSING WIPE |
| Product Code | HHL |
| Date Received | 2007-10-16 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 2085NBW |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 902115 |
| Manufacturer | JOHNSON & JOHNSON, INC. |
| Manufacturer Address | 7101 NOTRE DAME -EST MONTREAL, QUEBEC CA H9W 5N9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-10-16 |