MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-04-07 for RELINE-IT manufactured by Majestic Drug Co., Inc..
[72336476]
This report is generated as a result of a 12 month retrospective analysis of previous complaints. Device not returned for evaluation, product replaced to customer (b)(6) 2016.
Patient Sequence No: 1, Text Type: N, H10
[72336477]
The product is an otc denture reliner. The exact age and weight of the customer is not known. The customer has used the product several times before as indicated on his e-mail communication. In this instance the customer complained of a burn on the roof of his mouth and resulting pain the morning after. As a result he was not able to eat for 2 days or wear his partial appliance. The company replaced the product to the customer on (b)(6) 2016. The customer has not advised the company of any further discomfort or pain. No medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411564-2017-00001 |
| MDR Report Key | 6471495 |
| Report Source | CONSUMER |
| Date Received | 2017-04-07 |
| Date of Report | 2017-03-22 |
| Date of Event | 2016-07-15 |
| Date Mfgr Received | 2016-07-18 |
| Device Manufacturer Date | 2016-05-03 |
| Date Added to Maude | 2017-04-07 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR LARRY FISHMAN |
| Manufacturer Street | 4996 MAIN ST., ROUTE 42 POB 490 |
| Manufacturer City | SOUTH FALLSBURG NY 12779 |
| Manufacturer Country | US |
| Manufacturer Postal | 12779 |
| Manufacturer Phone | 8002380220 |
| Manufacturer G1 | MAJESTIC DRUG CO.,INC. |
| Manufacturer Street | 4996 MAIN ST., ROUTE 42 POB 490 |
| Manufacturer City | SOUTH FALLSBURG NY 12779 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12779 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELINE-IT |
| Generic Name | OTC DENTURE RELINER |
| Product Code | EBP |
| Date Received | 2017-04-07 |
| Model Number | RELINE-IT |
| Catalog Number | RELINE-IT |
| Lot Number | 16123 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAJESTIC DRUG CO., INC. |
| Manufacturer Address | 4996 MAIN ST., ROUTE 42 POB 490 SOUTH FALLSBURG NY 12779 US 12779 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-07 |