MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-01-09 for STRAUMANN EMDOGAIN 075.114 manufactured by Biora Ab.
[5414162]
Clinician reports lack of wound healing after a periodontal surgery to treat an intraosseous/furcation defect which was performed on (b)(6) 2014. Treatment site: fdi #21 - mp intrabony defect (5 mm intrabony component). Surgical technique was minimally invasive. On (b)(6) 2014 post-op symptoms included severe pain and discomfort with signs as severe swelling and necrosis. The clinician suspects an allergic reaction to the product.
Patient Sequence No: 1, Text Type: D, B5
[12921618]
The review of the risk management report "risk mgmt report - emd prefgel osteogain (b)(4) version 1. 0" confirms that incautious use in patients pre-disposed to allergic reactions is assessed and reflected in the ifu labelling 700019 straumann emdogain (us version). A previous evaluation by an allergist states that the allergy potential of emdogain is very low. The manufacturer reviewed manufacturing batch records for both 075. 114 lot gp625 (both emdogain and prefgel) and confirms that the product was released according to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2015-00002 |
| MDR Report Key | 4433297 |
| Report Source | 01,05 |
| Date Received | 2015-01-09 |
| Date of Report | 2015-01-08 |
| Date of Event | 2014-10-07 |
| Date Mfgr Received | 2014-11-04 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2015-02-03 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRAUMANN EMDOGAIN |
| Generic Name | BIOLOGIC MATERIAL, DENTAL |
| Product Code | NQA |
| Date Received | 2015-01-09 |
| Catalog Number | 075.114 |
| Lot Number | GP625 |
| Device Expiration Date | 2015-09-30 |
| 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 | 2015-01-09 |