MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-07 for REPAIR-IT manufactured by Majestic Drug Co., Inc..
[72417034]
This report is generated as a result of a 12 month retrospective analysis of previous complaints. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[72417035]
The product is an otc denture repair kit. The customer stated that she used the product and got sores in her mouth. She was unable to eat or wear dentures. As a result she went to the emergency room (er). The patient was prescribed antibiotics and told to use mouthwash. The customer was to follow-up with a private physician 1-2 days after. The customer had used the product previously with no adverse reaction. Follow-up calls were placed by company customer service with no answer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411564-2017-00002 |
| MDR Report Key | 6471501 |
| Date Received | 2017-04-07 |
| Date of Report | 2017-03-22 |
| Date of Event | 2016-06-20 |
| Date Mfgr Received | 2016-06-27 |
| Device Manufacturer Date | 2015-12-08 |
| 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 12279 |
| Manufacturer Country | US |
| Manufacturer Postal | 12279 |
| Manufacturer Phone | 8002380220 |
| Manufacturer G1 | MAJESTIC DRUG CO.,INC. |
| Manufacturer Street | 4996 MAIN ST. (ROUTE 42) POB 490 |
| Manufacturer City | SOUTH FALLSBURG NY 12279 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12279 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REPAIR-IT |
| Generic Name | OTC DENTURE REPAIR KIT. |
| Product Code | EBO |
| Date Received | 2017-04-07 |
| Model Number | REPAIR-IT |
| Catalog Number | REPAIR-IT |
| Lot Number | 15342 |
| 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. Hospitalization | 2017-04-07 |