MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for ELLIE FUN DAY manufactured by Drm Wood Products.
[138215721]
A customer informed us on (b)(6) 2019 that her (b)(6) old child dropped the wooden teether and it fell to the floor and cracked in half. The teether is made of hard american maple. We reached out to the customer to obtain additional information: the item was purchased sometime in (b)(6) 2018, and it was dropped at waist height (child was being carried) onto the floor. The item was not washed in the dishwasher per instructions on our website. We were not able to determine if the item had been dropped previously. We conducted some internal experiments to see if we were able to replicate the incident. We threw the item with lots of force and was unable to replicate the break. This item was tested to astm standards. All natural maple wood teether. Retailer: (b)(4). Retailer state: (b)(4). Purchase date: (b)(6) 2018. Contacted drm products for any support on what can be done to improve future product. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084709 |
| MDR Report Key | 8396799 |
| Date Received | 2019-03-06 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-02-11 |
| Date Added to Maude | 2019-03-06 |
| 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 | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELLIE FUN DAY |
| Generic Name | RING, TEETHING, NON - FLUID FILLED |
| Product Code | MEF |
| Date Received | 2019-03-06 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRM WOOD PRODUCTS |
| Manufacturer Address | 55 ROBEY RD TALLMADGE OH 44278 US 44278 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-06 |