MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-03 for COOL COMFORT TEETHER * manufactured by The First Years, Inc..
[46330]
There is a strong irritating odor that permeates this brand of teethers. Fda-approved preservatives are added to the distilled water inside the teether. A waiting period of 5 days prior to packaging is specified to allow any "smell" to go away. Co contracted mfr points to some rush shipments of this product where the 5-day spec may have been eliminated as the potential reason for the smell rptr encountered. The 5-day waiting period has now been mandated, without exception to avoid this problem in the future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001786 |
| MDR Report Key | 72968 |
| Date Received | 1997-03-03 |
| Date of Report | 1997-01-27 |
| Date Added to Maude | 1997-03-05 |
| 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 | COOL COMFORT TEETHER |
| Generic Name | FLUID FILLED TEETHING RING |
| Product Code | KKO |
| Date Received | 1997-03-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 72824 |
| Manufacturer | THE FIRST YEARS, INC. |
| Manufacturer Address | ONE KIDDIE DR AVON MA 023221171 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-03 |