MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-06 for WEETHUMBIE * 94036 manufactured by Children's Medical Ventures, Inc..
[41420]
Human hair in unopened package.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001797 |
| MDR Report Key | 74150 |
| Date Received | 1997-03-06 |
| Date of Report | 1997-02-26 |
| Date Added to Maude | 1997-03-10 |
| 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 |
| 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 | WEETHUMBIE |
| Generic Name | PREEMIE PACIFIER |
| Product Code | LQX |
| Date Received | 1997-03-06 |
| Model Number | * |
| Catalog Number | 94036 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 73980 |
| Manufacturer | CHILDREN'S MEDICAL VENTURES, INC. |
| Manufacturer Address | 541 MAIN ST S WEYMOUTH MA 02190 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-06 |