MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-12 for ALWAYS * manufactured by Procter & Gamble.
[19260539]
Product is a single wrapped item. Complainant opened individual package and noticed something in the "shell" of the sanitary pad. Initially thought it looked like a "rat dropping" and contacted the environmental health svs in their co. Object was later identified as "fly pulpa case". Complainant stopped using product in 02/2001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002948 |
| MDR Report Key | 320150 |
| Date Received | 2001-03-12 |
| Date of Report | 2001-02-26 |
| Date of Event | 2001-02-01 |
| Date Added to Maude | 2001-03-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYS |
| Generic Name | SANITARY PAD, OVERNIGHT |
| Product Code | HHL |
| Date Received | 2001-03-12 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | 0314CA11671537 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 309674 |
| Manufacturer | PROCTER & GAMBLE |
| Manufacturer Address | 1 PROCTER & GAMBLE PLAZA CINCINNATI OH 45202 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-03-12 |