MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2005-02-18 for EMDOGAIN 075.103 manufactured by Biora Ab.
[17024509]
The initial information received reported that a pt died 2 days after perio surgery during which emdogain was used. The dentist stated that this event had nothing to do with the perio surgery or emdogain. The dentist had treated this pt 3 times surgically prior (this was the first time emdogain was used). The pt was suspected to have a condition called dic. In this condition platelets break down rapidly profuse bleeding can occur. An autopsy will be performed. The dentist did prescribe amoxicillin and ibuprofen. Other medications unknown. The clinician later spoke to the medical examiner and learned that it appears that the pt had an autoimmune problem. They no longer suspect dic since the pt had bleeding around the heart and lungs and not at the surgical site. With dic they would have expected bleeding at the surgical site. The clinician still anticipate that he will receive a copy of the autopsy report, however this will take another 6-8 weeks. The medical examiner did not seem concerned about emdogain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222315-2005-00001 |
| MDR Report Key | 574068 |
| Report Source | 07,08 |
| Date Received | 2005-02-18 |
| Date of Event | 2005-01-14 |
| Date Mfgr Received | 2005-01-18 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2005-02-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1601 TRAPELO ROAD |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 4640321332 |
| Manufacturer G1 | BIORA AB |
| Manufacturer Street | MEDEON SCIENCE PARK |
| Manufacturer City | MALMO SE-205 1 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-205 12 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMDOGAIN |
| Generic Name | ENAMEL MATRIX DERIVATIVE |
| Product Code | NQA |
| Date Received | 2005-02-18 |
| Model Number | NA |
| Catalog Number | 075.103 |
| Lot Number | 1033 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 563934 |
| Manufacturer | BIORA AB |
| Manufacturer Address | * MALMO SW |
| Baseline Brand Name | EMDOGAIN |
| Baseline Generic Name | ENAMEL MATRIX DERIVATIVE |
| Baseline Model No | NA |
| Baseline Catalog No | 075.103 |
| Baseline ID | NA |
| Baseline Device Family | EMDOGAIN |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9300 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-02-18 |