MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-07-21 for CAREFREE PANTY SHIELDS 123420 manufactured by Personal Products Co.
[18193606]
Consumer reported having an allegic reaction after wearing a pad for light drainage after a partial hysterectomy and bladder repair. The consumer was hospitalized for one day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1483030-2000-00001 |
| MDR Report Key | 286771 |
| Report Source | 04 |
| Date Received | 2000-07-21 |
| Date of Report | 2000-06-22 |
| Date of Event | 2000-06-05 |
| Date Mfgr Received | 2000-06-22 |
| Date Added to Maude | 2000-07-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOSEPH KICEINA |
| Manufacturer Street | 199 GRANDVIEW RD |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9088741216 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREFREE PANTY SHIELDS |
| Generic Name | MENSTRUAL PAD |
| Product Code | HHL |
| Date Received | 2000-07-21 |
| Model Number | NA |
| Catalog Number | 123420 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 277500 |
| Manufacturer | PERSONAL PRODUCTS CO |
| Manufacturer Address | KANKAKEE RIVER DR WILMINGTON IL 60481 US |
| Baseline Brand Name | CAREFREE PANTILINERS |
| Baseline Generic Name | SCENTED MENSTRUAL PAD |
| Baseline Model No | NA |
| Baseline Catalog No | 123420 |
| Baseline ID | NA |
| Baseline Device Family | SCENTED MENSTRUAL PAD |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K792195 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2000-07-21 |