FDA Adverse Event
Injury
Summary report: N
MICRO AQ+, 3-0 ETHBND (V4) W/1.3MMBIT
MDR report key: 1790785
·
Received August 4, 2010
Report
- Report Number
- 1221934-2010-00274
- Event Type
- Injury
- Date Received
- August 4, 2010
- Date of Event
- July 4, 2010
- Report Date
- July 27, 2010
- Manufacturer
- DEPUY MITEK
- Product Code
- MBI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AT THIS POINT IN TIME MITEK IS IN THE INFORMATION GATHERING MODE. IF AND WHEN MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT IN.
Description of Event or Problem · 1
DOCTOR HAD TO REMOVE MICRO ANCHOR FROM PATIENT, FOR THEY WERE EXPELLED FROM BONE, DUE TO A FOREIGN BODY REACTION WERE CYSTS HAD FORMED. THE ANCHORS REMOVED HAD BEEN PLACED IN THE PHALANGES 3 AREA OF THE FINGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO AQ+, 3-0 ETHBND (V4) W/1.3MMBIT | MICRO QA+ANCHOR | MBI | DEPUY MITEK | 212865 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |