MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-11-01 for CAREFREE BODY SHAPE LONG PANTILINERS manufactured by Johnson & Johnson, Inc..
[17059730]
Consumer information center received a complaint on october 22, 2007. Consumer reported that she used the product several times since approximately 2006. In 2007, she developed a urinary tract infection (uti) that led to septicemia, and almost death. At that time, she was hospitalized for 10 days. She is unsure if uti was caused from the use of product. She has continued to use the product through this month, and is now experiencing burning in urination, which may be another uti. Consumer no longer has the box that she used in may preceding the hospitalization. Her symptoms persists. Consumer was advised to discontinue the use of product, and consult her physician. Consumer information center attempted to contact the consumer on 10/22/2007. No response by the consumer. This report is closed unless new, significant information is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022269-2007-00012 |
| MDR Report Key | 936641 |
| Report Source | 04 |
| Date Received | 2007-11-01 |
| Date of Report | 2007-10-31 |
| Date of Event | 2007-05-01 |
| Date Mfgr Received | 2007-10-22 |
| Date Added to Maude | 2007-11-07 |
| 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 | 3 |
| 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 | CAREFREE BODY SHAPE LONG PANTILINERS |
| Generic Name | MENSTRUAL PAD |
| Product Code | HHL |
| Date Received | 2007-11-01 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 910499 |
| Manufacturer | JOHNSON & JOHNSON, INC. |
| Manufacturer Address | 7101 NOTRE DAME EST, MONTREAL, QUEBEC CA H9W 5N9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2007-11-01 |