FDA Adverse Event
Injury
Summary report: N
COAPT SYSTEMS, INC.
MDR report key: 2026328
·
Received March 17, 2011
Report
- Report Number
- 2020601-2011-00003
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 15, 2011
- Manufacturer
- COAPT SYSTEMS, INC.
- Product Code
- HWC
- PMA / PMN Number
- K060249
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
DUE TO SECOND PROCEDURE REQUIRED IN ORDER TO REMOVE ENCAPSULATION / IMPLANT, IT WAS DETERMINED THAT EVENT WAS REPORTABLE TO THE F.D.A.
Description of Event or Problem · 1
REC'D REPORT FROM CUSTOMER INDICATING THAT ENCAPSULATION HAD OCCURRED FROM AN IMPLANT WHICH WAS ORIGINALLY INSTALLED ON (B)(6) 2010. THE ENCAPSULATION REQUIRED A SECOND SURGERY TO BE PERFORMED ON (B)(6) 2011 TO REMOVE THE ENCAPSULATED AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAPT SYSTEMS, INC. | ULTRATINE (FIXATION DEVICE) | HWC | COAPT SYSTEMS, INC. | 23202 | 2756 (QTY. 1) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |