MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-06-28 for STAYFREE MAXI SUPER COTTON DRY COVER manufactured by Johnson & Johnson, Inc..
[1613934]
Consumer reports she always used (b)(4) since everyone else started using dry weave because she is allergic. She is writing to inform us about a severe allergic reaction she had to our new thermo control lining. She uses 4 to 5 pads daily due to light incontinence. During that period of time she began developing a rash that slowly spread from front to back (including her anal area). It began as a slight itching and then developed into a full blown rash with swelling, burning and intense unbearable itching. Pt is one week into the healing process but still has pain and itching.
Patient Sequence No: 1, Text Type: D, B5
[8556331]
Date of this submission is (b)(4), 2010. This closes out this report unless additional significant info is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022269-2010-00001 |
| MDR Report Key | 1752847 |
| Report Source | 04 |
| Date Received | 2010-06-28 |
| Date of Report | 2010-06-02 |
| Date Mfgr Received | 2010-06-02 |
| Date Added to Maude | 2011-04-26 |
| 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 | NANCY REGULSKI |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089043329 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAYFREE MAXI SUPER COTTON DRY COVER |
| Generic Name | PAD, MENSTRUAL |
| Product Code | HHD |
| Date Received | 2010-06-28 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON, INC. |
| Manufacturer Address | 7101 NOTRE DAME ST. EAST MONTREAL H1N2G4 CA H1N2G4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-06-28 |