MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-07-11 for STRAUMANN EMGOGAIN 075-113 manufactured by Biora Ab,.
[3599210]
Clinician reports that he carried out a connective tissue graft (autogenous) + caf on a pt using emdogain (075. 113 lot fk781). About 3 days post op there was abnormal swelling. This event is reported to have happened on (b)(6) 2013. The clinician re-flapped and re-applied emdogain (075. 113 lot fh765) and had swelling again. This event is reported to have happened on (b)(6) 2013. He reports possible allergic reaction. He is going to explore any allergies that the pt might have and put her on antihistamines. Add'l info provided by the clinician on (b)(6) 2013 states that the swelling and tissue dehiscence has persisted for two weeks.
Patient Sequence No: 1, Text Type: D, B5
[10967826]
The review of the risk management report "risk mgmt report_emdogain_prefgel_v3" confirm that the use on pts showing previous sensitization to emdogain is assessed and reflected in the ifu labelling 700019 straumann emdogain (us version). This labelling states under: warning: immunological studies suggest that a small number of pts may become sensitized to emdogain as a result of repeated use. Please see caution in pts predisposed to allergic reactions and follow pts receiving repeated use closely. Post-market experience has indicted that the sensitization adverse reaction rate is low. Required treatment has ranged from no intervention needed to analgesics and/or antihistamines. " precautions: clinical and radiographic eval should be preformed before treatment. The review of the complaints database confirms that no further similar complaints with these article and lot numbers have been registered. The mfr reviewed mfg batch records for both 075. 113 lot fk781 and 075. 113 lot fh765 and confirms that the product was released according to spec. A previous evaluation by an allergist states that the allergy potential of emdogain is very low.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2013-00003 |
| MDR Report Key | 3227290 |
| Report Source | 05 |
| Date Received | 2013-07-11 |
| Date of Report | 2013-07-11 |
| Date of Event | 2013-06-02 |
| Date Mfgr Received | 2013-06-13 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2013-07-26 |
| 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 EMGOGAIN |
| Generic Name | BIOLOGIC MATERIAL, DENTAL |
| Product Code | NQA |
| Date Received | 2013-07-11 |
| Catalog Number | 075-113 |
| Lot Number | FK781 |
| Device Expiration Date | 2014-11-30 |
| 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 | 2013-07-11 |