MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for EQUATE DENTURE ADHESIVE 5502C manufactured by Sheffield Pharmaceuticals Llc.
[138207970]
Patient Sequence No: 1, Text Type: N, H10
[138207971]
Patient stated that he was hospitalized with stomach problems since using the eq denture adhesive. Customer said that he has had a problem with his stomach from when he first started using dentures but never had to go to the hospital. Customer was not able to supply the lot #.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1210513-2018-00183 |
| MDR Report Key | 8400125 |
| Date Received | 2019-03-07 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-12-27 |
| Date Reported to Mfgr | 2018-12-27 |
| Date Mfgr Received | 2018-12-27 |
| Device Manufacturer Date | 2018-10-22 |
| Date Added to Maude | 2019-03-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR ANTHONY SOLLIMA |
| Manufacturer Street | 170 BROAD ST |
| Manufacturer City | NEW LONDON CT 06320 |
| Manufacturer Country | US |
| Manufacturer Postal | 06320 |
| Manufacturer Phone | 8604424451 |
| Manufacturer G1 | SHEFFIELD PHARMACEUTICALS LLC |
| Manufacturer Street | 170 BROAD ST |
| Manufacturer City | NEW LONDON CT 06320 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06320 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EQUATE DENTURE ADHESIVE |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2019-03-07 |
| Model Number | 5502C |
| Lot Number | 80481 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHEFFIELD PHARMACEUTICALS LLC |
| Manufacturer Address | 170 BROAD ST NEW LONDON CT 06320 US 06320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-03-07 |