MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-30 for ORAFIX SPECIAL DEN. ADHESIVE * manufactured by Hogil Pharmaceutical Corp..
[20684334]
Rptr telephoned smithkline beecham, and was informed that this product was sold to hogil pharmaceutical corp. On april 1, 1996 and that they were now the mfr. The rptr has 2 questions. Who manufactures this product? What are the ingredients?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012429 |
| MDR Report Key | 130354 |
| Date Received | 1997-10-30 |
| Date of Report | 1997-10-29 |
| Date of Event | 1997-06-01 |
| Date Added to Maude | 1997-11-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORAFIX SPECIAL DEN. ADHESIVE |
| Generic Name | * |
| Product Code | KOQ |
| Date Received | 1997-10-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 70313 |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 127482 |
| Manufacturer | HOGIL PHARMACEUTICAL CORP. |
| Manufacturer Address | 1 BYRMBROOK PL. ARMONK NY 1050 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-30 |