FDA Adverse Event
Malfunction
Summary report: N
HEMOLOK REMOVER XL/L ENDO
MDR report key: 1713807
·
Received May 28, 2010
Report
- Report Number
- 1044475-2010-00058
- Event Type
- Malfunction
- Date Received
- May 28, 2010
- Report Date
- May 6, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- HBQ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE WILL BE RETURNED FOR INVESTIGATION. EVAL: CONCLUSION - THE REPAIR FACILITY UNABLE TO DIAGNOSE ROOT CAUSE. DEFECTIVE SAMPLE WAS DISCARDED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE COMPLAINT WAS FORWARDED THROUGH VENDOR REPAIR TO THE MFR ON (B)(6) 2010. FURTHER INFO REVEALED THE DEVICE WAS BEING USED DURING A DEMONSTRATION WHEN THE HANDLE BROKE. NOT USED ON A PT. NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOLOK REMOVER XL/L ENDO | CLIP REMOVER | HBQ | TELEFLEX MEDICAL | NA | 1691221-042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |