MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-19 for TAP III manufactured by Prismatik Dentalcraft, Inc..
[185910270]
The patients weight is not provided as it is not taken at the time of the appointment. Exact date of event was not provided when asked. Not applicable for this device with the exception of the lot number and the operator of the device. The device has not been returned. If/when the device is returned an investigation will be carried out and a supplemental report will be submitted. This is the first of two implant complaints, see manufacturer report for the remaining complaint : 3011649314-2020-00472 ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[185910271]
It was reported that the patient had a possible allergic reaction after using tap 3 sleep device. The provider notes that the patient received the device on (b)(6) 2019 and shortly thereafter developed rash noting the location as "intraoral and lingual center of lips. " the provider states that the patient was not allergy tested prior to the delivery of the device. He further states that the patient was provided care instructions: "wash with warm water and soap and leave to air dry. " the date of event occurred "after a couple of days of using the device. " the provider notes the patient saw the primary care provider and was given antibiotics (unknown medication). The primary care provider instructed the patient to stop using the device and try again after a couple of days. The patient again experienced a painful rash on the lingual tissue portion of the lips. The provider states, "the patient may consider taking an allergy test. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011649314-2020-00471 |
| MDR Report Key | 9728463 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2019-11-12 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. HERBERT SCHOENHOEFER |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4402632 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Street | 2212 DUPONT DR SUITE P |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAP III |
| Generic Name | TAP III |
| Product Code | LRK |
| Date Received | 2020-02-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISMATIK DENTALCRAFT, INC. |
| Manufacturer Address | 2212 DUPONT DRIVE SUITE P IRVINE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-19 |