MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2010-02-05 for EMDOGAIN 075.113 manufactured by Biora Ab.
[1421076]
Pt reports a number of complaints over a period of several months that include swelling and soreness in jaw, stiffness, tightness, itching, arm and leg pain, discomfort, shooting pain, pressure in head, stiff neck, swelling and tenderness of carotid artery, pulsing in ear, weakness and numbness, heat in ears and head, unable to speak normally, sunburn feeling, need to clear throat, gravelly voice, a "string under skin is gliding over my left shoulder while stretching", eyes bloodshot upon waking. After physical therapy, arm feels like it will fall off, crying with "thick tears", interrupted sleep with congestion. Dull ache and "string floating across back/right shoulder blade. Touching string makes right sinus clear. " finds neck mass that goes away 20 minutes after taking amoxicillin. "pressure events" occurring. Thick saliva/mucous in mouth, fullness in head. Night sweats. Reports of pain in both left and right side.
Patient Sequence No: 1, Text Type: D, B5
[8454104]
Symptoms and tests/additional clinician visits were reported to the treating clinician by the pt. Initial product use was on (b) (6) 2009, on the right side of mouth. The clinician was contacted for additional info. Clinician reports that the pt was referred to the clinician for pain. Pt reported pain on the day of surgery. Follow up visit by the clinician on (b) (6) 2009, revealed the site looked fine locally. No concerns regarding the use of the product was raised to the clinician by the pt at this visit. Although requested, no results from tests have been provided to the clinician. No known diagnosis has been communicated. Pt failed to appear for subsequent follow up appointment. Clinician reports that she has never seen anything like this before and has used the product for yrs. Mfr review of concomitant medicines indicate that some of these symptoms are identified in product labeling for those medicines. Mfr reviewed mfg batch records and no discrepancies were found. No other similar reports have been filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2010-00005 |
| MDR Report Key | 1604498 |
| Report Source | 04,05 |
| Date Received | 2010-02-05 |
| Date of Report | 2010-02-05 |
| Date Mfgr Received | 2010-01-11 |
| Date Added to Maude | 2010-02-24 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | LISA QUAGLIA, US AGENT |
| Manufacturer Street | 60 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787472575 |
| 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 | EMDOGAIN |
| Generic Name | BIOLOGIC MATERIAL, DENTAL |
| Product Code | NQA |
| Date Received | 2010-02-05 |
| Catalog Number | 075.113 |
| Lot Number | H0933 |
| Device Expiration Date | 2009-06-30 |
| 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. Required No Informationntervention | 2010-02-05 |