MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-21 for THE WEE SOOTHER manufactured by Children's Medical Ventures.
[208853]
Oily film all over the pacifier. Took it back and was given another one, same problem. The oily film could not be wiped-off.
Patient Sequence No: 1, Text Type: D, B5
[17428072]
Add'l info rec'd from mfr 11/2/01: in response to the medwatch report, mfr immediately contact supplier, a molding operation. The response confirmed that there are no oils used in the molding and packaging of the pacifiers. Since there are no available parts (pacifiers with reported oil), mfr is unable to investigate this claim any further. In support of firm's belief that this report is not reflective of its style pacifiers, mfr submits the following; children's medical ventures has distributed in excess of 5 million pacifiers (all types) in the past two years without any report of oil or similar contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003122 |
| MDR Report Key | 355300 |
| Date Received | 2001-08-21 |
| Date of Report | 2001-08-21 |
| Date of Event | 2001-08-01 |
| Date Added to Maude | 2001-10-12 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | THE WEE SOOTHER |
| Generic Name | PACIFIER |
| Product Code | LQX |
| Date Received | 2001-08-21 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 344522 |
| Manufacturer | CHILDREN'S MEDICAL VENTURES |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-08-21 |