MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-11-25 for STAYFREE DEODORANT MAXI UNK manufactured by Johnson & Johnson Inc..
[17022925]
Pt reported using the product 3 times in 2009. She was hospitalized due to a urinary tract infection and kidney infection, and treated with bactrim and ciprofloxacin and iv fluids. The doctor stated that the infection was related to the deodorant in the pad. She was hospitalized for 3 - 4 days.
Patient Sequence No: 1, Text Type: D, B5
[17230474]
This closes out this report unless additional significant info is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022269-2009-00005 |
| MDR Report Key | 1546401 |
| Report Source | 04 |
| Date Received | 2009-11-25 |
| Date of Report | 2009-11-12 |
| Date of Event | 2009-11-10 |
| Date Mfgr Received | 2009-11-10 |
| Date Added to Maude | 2009-12-02 |
| 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 RD |
| 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 H1N1GA |
| Manufacturer Country | CA |
| Manufacturer Postal Code | H1N 1GA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAYFREE DEODORANT MAXI |
| Generic Name | MENSTRUAL PAD, SCENTED |
| Product Code | HHL |
| Date Received | 2009-11-25 |
| Model Number | UNK |
| Lot Number | UNK |
| 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 | 2009-11-25 |