MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-24 for EMDOGAIN 0.3 ML MULTI, USA 075.103 manufactured by Biora Ab.
[530348]
The clinician states, that the patient had the implant placed in site #8 in 2006. The clinician reports, that the patient had 8-9mm pockets between sites #8 & #9. The patient returned fifteen days later for suture removal, nothing noted. The patient returned for a follow up , nothing noted. Seventeen days later, the clinician received a note from the patient that during routine lab work with her primary care physician, she was found to have low platelet count. A secondary lab work was run to confirm the findings and she was placed on prednisone for thrombocytopenia. She was advised that a side effect of one medication that she took (doxycycline) can cause thrombocytopenia, and was wondering if there were any experiences like this in the past with the clinician. The patient indicates she is responding well to treatment.
Patient Sequence No: 1, Text Type: D, B5
[7800824]
Thrombocytopenia often occurs as a result of another underlying disease or disorder, and can be a known side effect of certain drugs such as doxcycline, which the patient had reportedly been taking recently. The manufacturer will follow up with the clinician to determine the current status of the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2006-00002 |
| MDR Report Key | 774304 |
| Report Source | 05 |
| Date Received | 2006-10-24 |
| Date of Report | 2006-10-24 |
| Date of Event | 2006-02-02 |
| Date Facility Aware | 2006-03-24 |
| Report Date | 2006-10-24 |
| Date Reported to Mfgr | 2006-05-23 |
| Date Mfgr Received | 2006-05-23 |
| Device Manufacturer Date | 2003-12-01 |
| Date Added to Maude | 2006-10-31 |
| 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 | ANN JOHANSSON |
| Manufacturer Street | MEDEON SCIENCE PARK |
| Manufacturer City | MALMO 20512 |
| Manufacturer Country | SW |
| Manufacturer Postal | 20512 |
| Manufacturer Phone | 0321332 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMDOGAIN 0.3 ML MULTI, USA |
| Generic Name | ENAMEL DERIVATIVE |
| Product Code | NQA |
| Date Received | 2006-10-24 |
| Model Number | NA |
| Catalog Number | 075.103 |
| Lot Number | 1018 |
| ID Number | NA |
| Device Expiration Date | 2005-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 762084 |
| Manufacturer | BIORA AB |
| Manufacturer Address | * MALMO SW |
| Baseline Brand Name | EMDOGAIN |
| Baseline Generic Name | ENAMEL MATRIX DERIVATIVE |
| Baseline Model No | NA |
| Baseline Catalog No | 075.103 |
| Baseline ID | NA |
| Baseline Device Family | EMDOGAIN |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9300 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-10-24 |