FDA Adverse Event
Malfunction
Summary report: N
WECK HEMOLOK TAKEAPART XL 10MM ENDO APPLIER
MDR report key: 2844719
·
Received November 9, 2012
Report
- Report Number
- 3005236665-2012-00011
- Event Type
- Malfunction
- Date Received
- November 9, 2012
- Date of Event
- October 9, 2012
- Report Date
- October 24, 2012
- Manufacturer
- KMEDIC EUROPE GMBH, PILLING WECK
- Product Code
- GAD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: ALLEGED ISSUE: THE BLACK HEAD ON THE SHAFT HAD BEEN SOLDERED ON, SO EVENTUALLY THE BLACK HEAD FELL OFF. THIS OCCURRED DURING USE ON A PATIENT. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WECK HEMOLOK TAKEAPART XL 10MM ENDO APPLIER | ENDO APPLIER | GAD | KMEDIC EUROPE GMBH, PILLING WECK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |