MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2006-01-30 for FIRST YEARS ANIMAL TEETHER Y1473 manufactured by Rc2 Brands, Inc. The First Years.
[756538]
Pt has been diagnosed with pseudomonas aeruginosa due to possible ingestion of fluid from a recalled first yrs animal teether. Before diagnosis, complainant stated that his son was using an animal teether mfd by first yrs. Complainant stated that his son bit into the teether about four months ago and he noticed the liquid missing. He contacted poison control, who informed him that the liquid inside the teether was non-toxic. Since that time, his son has reportedly been in and out of the hospital due to continuous coughing. During the last visit to the hosp, his son was reportedly diagnosed with the above bacteria. Upon reading the local newspaper over the weekend, the complainant realized the first yrs teether he had purchased for his son was involved in a recall. His son reportedly will be starting the antibiotic cipro.
Patient Sequence No: 1, Text Type: D, B5
[8037645]
In 2006, we initiated a voluntary recall with fda for six (6) styles of waterfilled teether product. On august, 14, 06 fda sent a letter to advise us that they consider the recall terminated. Because of the ambiguity of the fda's rules, the mfr was unaware that a medwatch report might be required for an incident already reported to fda by the pt for a device that has already been the subject of an fda-monitored recall. Because the device has already been recalled, the mfr submits that no adverse consequences flow from the timing of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217805-2006-00001 |
| MDR Report Key | 964304 |
| Report Source | 00,04 |
| Date Received | 2006-01-30 |
| Date of Report | 2006-01-30 |
| Date of Event | 2006-01-30 |
| Date Added to Maude | 2007-12-17 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 100 TECHNOLOGY CENTER DR STE 2A |
| Manufacturer City | STOUGHTON MA 02072 |
| Manufacturer Country | US |
| Manufacturer Postal | 02072 |
| Manufacturer Phone | 7813416250 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | RECALL Z-455/460-6 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIRST YEARS ANIMAL TEETHER |
| Generic Name | WATERFILLED TEETHER RING |
| Product Code | KKO |
| Date Received | 2006-01-30 |
| Model Number | Y1473 |
| Catalog Number | Y1473 |
| Lot Number | VARIOUS |
| ID Number | UPC# 071463014736 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 696999 |
| Manufacturer | RC2 BRANDS, INC. THE FIRST YEARS |
| Manufacturer Address | * STOUGHTON MA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-01-30 |