MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-13 for EMDOGAIN 075.101 manufactured by Biora Ab.
[1765181]
Immediately after surgery with emdogain and prefgel, when making the suture, the right part of the pt's face swelled from eye down to throat. Pt got an injection by the general doctor and now everything is ok. The face is not swollen anymore and the pt is well. It is not known which other products were used in conjunction with this surgery, e. G local anesthesia, which more often than emdogain triggers allergic reactions. Possibly, a similar product that was used 50 years ago and then caused the swelling, also caused it now.
Patient Sequence No: 1, Text Type: D, B5
[8867048]
Manufacturer reviewed manufacturing batch records and no discrepancies were found. An allergy test is being conducted and the manufacturer expects to be made aware of the results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2010-00020 |
| MDR Report Key | 1943608 |
| Report Source | 05 |
| Date Received | 2010-12-13 |
| Date of Report | 2010-12-10 |
| Date Mfgr Received | 2010-11-11 |
| Date Added to Maude | 2012-03-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BERNIE MCDONALD |
| Manufacturer Street | 60 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787472514 |
| Manufacturer G1 | BIORA, AB |
| Manufacturer Street | MEDEON SCIENCE PARK |
| Manufacturer City | MALMO |
| Manufacturer Country | SW |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMDOGAIN |
| Generic Name | BIOLOGIC MATERIAL, DENTAL |
| Product Code | NQA |
| Date Received | 2010-12-13 |
| Catalog Number | 075.101 |
| Lot Number | Z3144 |
| Device Expiration Date | 2012-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIORA AB |
| Manufacturer Address | MALMO SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-12-13 |