MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-11-08 for STRAUMANN EMDOGAIN 075.114 manufactured by Biora Ab.
[3983521]
According to the information provided on (b)(6) 2013 the customer reports that they had an issue with a patient recently treated with emdogain. The patient developed a sort of cutaneous reaction whose origin cannot be detected. The clinician requested a technical sheet of emdogain reporting technical specifications of the product, sterilization etc. Based on the telephone conversation between stit complaint handling and the customer on (b)(6) 2013 additional information was requested. The customer used article 075. 114 emdogain 0. 3ml multipack lot number ea593. The surgery using emdogain and prefgel was carried out in (b)(6) on (b)(6) 2012. The event date is (b)(6) 2012. The customer reports there was swelling and inflammation. We presume that the prefgel used also came from the article 075. 114 lot ea593. The clinician provided additional information on (b)(6) 2013. The clinician reports that the patient has a bulge. No treatment has been administered to the patient as the clinician has to investigate the reasons of the reaction.
Patient Sequence No: 1, Text Type: D, B5
[11456692]
Material safety data sheet was sent to customer as requested. The risk management report "risk mgmt report_emdogain-prefgel_v3" has identified that the use of emdogain in patients with compromised health conditions or in patients pre-disposed to allergic reactions might result in a body reaction (e. G. Allergic reaction) and is reflected in the eu ifu labelling 70016 / 701354. This labelling states that the "straumann product must be used in accordance with the instructions for use provided by the manufacturer. It is the practioner's responsibility to use the device in accordance with these instructions for use and to determine if the device fits to the individual patient situation. " the manufacturer reviewed manufacturing batch records for 075. 114 lot ea593 which contains emdogain batch ch476b and prefgel batch ae811. All products were released according to specifications. Review of the complaints database also confirmed that no further complaints have been reported with this article and lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2013-00004 |
| MDR Report Key | 3530571 |
| Report Source | 01,05 |
| Date Received | 2013-11-08 |
| Date of Report | 2013-11-08 |
| Date of Event | 2012-12-01 |
| Date Mfgr Received | 2013-10-11 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2014-01-07 |
| 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 |
| 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 | 2013-11-08 |
| Catalog Number | 075.114 |
| Lot Number | EA593 |
| Device Expiration Date | 2013-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-11-08 |