MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for PLACKERS KDS DUAL GRP FR SMTH 75 PKFL KDS DUAL GRP FR SMTH 75 manufactured by Ranir Llc.
[148427680]
Reporter stated that her child is allergic to pineapple and her child reacted almost immediately after using the product. She immediately had an itchy tongue and face upon contact with the product. She is almost 11 and pineapple is her only allergy. The symptoms lasted about 30 minutes and were rectified with benadryl. Product was returned for review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2019-00572 |
| MDR Report Key | 8693476 |
| Date Received | 2019-06-12 |
| Date of Report | 2019-06-12 |
| Date of Event | 2019-05-06 |
| Date Facility Aware | 2019-05-24 |
| Date Mfgr Received | 2019-05-24 |
| Date Added to Maude | 2019-06-12 |
| 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 | 3 |
| Manufacturer Contact | REBEKAH STENSKE |
| Manufacturer Street | 4701 EAST PARIS AVE. SE |
| Manufacturer City | GRAND RAPIDS MI 495125353 |
| Manufacturer Country | US |
| Manufacturer Postal | 495125353 |
| Manufacturer Phone | 6166988880 |
| Manufacturer G1 | RANIR LLC |
| Manufacturer Street | 4701 EAST PARIS AVE. SE |
| Manufacturer City | GRAND RAPIDS MI 495125353 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 495125353 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PLACKERS KDS DUAL GRP FR SMTH 75 |
| Generic Name | FLOSS, DENTAL |
| Product Code | JES |
| Date Received | 2019-06-12 |
| Returned To Mfg | 2019-05-24 |
| Model Number | PKFL KDS DUAL GRP FR SMTH 75 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RANIR LLC |
| Manufacturer Address | 4701 EAST PARIS AVE. SE GRAND RAPIDS MI 49512 US 49512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-12 |