MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-06-08 for CAREFREE TO GO PANTILINERS manufactured by Personal Products Co..
[15034738]
Record came through our corporate legal department. Client alleges vaginal abscess and urinary tract infection related to product use. Incident date was on or around 2004. Corporate legal department notified medical services. A search of our records yielded no previous record of consumer contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2214133-2006-00003 |
| MDR Report Key | 753028 |
| Report Source | 07 |
| Date Received | 2006-06-08 |
| Date of Report | 2006-06-06 |
| Date of Event | 2004-10-01 |
| Date Facility Aware | 2005-11-02 |
| Report Date | 2006-06-01 |
| Date Reported to Mfgr | 2006-06-01 |
| Date Added to Maude | 2006-08-23 |
| 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 | 3 |
| Manufacturer Street | 199 GRANDVIEW ROAD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9088741402 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREFREE TO GO PANTILINERS |
| Generic Name | MENSTRUAL PAD |
| Product Code | HHL |
| Date Received | 2006-06-08 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 740829 |
| Manufacturer | PERSONAL PRODUCTS CO. |
| Manufacturer Address | 199 GRANDVIEW RD. SKILLMAN NJ 08558 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-08 |