FDA Adverse Event
Injury
Summary report: N
ENDOTINE TRANSBLEPH 3.5
MDR report key: 1663475
·
Received April 16, 2010
Report
- Report Number
- 3003644133-2010-00004
- Event Type
- Injury
- Date Received
- April 16, 2010
- Date of Event
- January 4, 2010
- Report Date
- March 23, 2010
- Manufacturer
- COAPT SYSTEMS, INC.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE BATCH RECORD FOR THIS LOT HAS BEEN REVIEWED, WHICH CONTAINS NO ABNORMAL MFG EVENTS. THE COMPLAINT RATE FOR THIS LOT IS NOT ABNORMAL. THE PHYSICIAN IMPLANTED DEVICES 3.5 MONTHS AFTER THE LABELED EXPIRATION DATE.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE PHYSICIAN IMPLANTED THE DEVICE (B) (6) 2009. ON (B) (6) 2010, THE PHYSICIAN PERFORMED A SECOND SURGERY BECAUSE THE DEVICE DID NOT ACHIEVE THE DESIRED COSMETIC BENEFIT. THE DEVICE HAD COMPLETELY ABSORBED AT THE TIME OF THE SECOND SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTINE TRANSBLEPH 3.5 | SMOOTH METALLIC BONE FIXATION FASTENER | HWC | COAPT SYSTEMS, INC. | CFD-080-0167 | 01570 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |