MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-25 for STRAUMANN EMDOGAIN 975.113 manufactured by Biora Ab.
[21672491]
Clinician reports that he used emdogain in the treatment of a class 2 facial furcation in site 19 on (b)(6) 2012. He debrided the site, used prefgel and then emdogain. Normal post-op. Two weeks later the pt presented with moderate pain in site. The site was erosive with dramatic erythema and edema. Clinician reports that the general observation on wound healing was that it was irritated and inflamed. Healing remarkably slow with significant slough of attached tissue. Appears to be localized allergic reaction. The flap was not too thin nor was the vasculature compromised. A further surgery is necessary to correct the soft tissue result defects.
Patient Sequence No: 1, Text Type: D, B5
[21886896]
The article and lot number of the emdogain was not reported by the clinician to straumann. However, additional info received on (b)(6) 2012 from the clinician states that the op took place on (b)(6) 2012. (b)(4). The review of the complaints database confirmed that we have not received any further similar complaints with this lot number. The mfr received mfr reviewed mfg batch records and confirms that the product was release according to specification. A previous evaluation by an allergist status that the allergy potential of emdogain is very low.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2012-00017 |
| MDR Report Key | 2823748 |
| Report Source | 05 |
| Date Received | 2012-10-25 |
| Date of Report | 2012-10-30 |
| Date of Event | 2012-07-06 |
| Date Mfgr Received | 2012-08-09 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-11-28 |
| 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 | 2012-10-25 |
| Catalog Number | 975.113 |
| Lot Number | CR333 |
| Device Expiration Date | 2013-06-30 |
| 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 | 2012-10-25 |