FDA Adverse Event
Other
Summary report: N
DEROYAL
MDR report key: 3521382
·
Received December 6, 2013
Report
- Report Number
- 2320762-2013-00006
- Event Type
- Other
- Date Received
- December 6, 2013
- Date of Event
- November 6, 2013
- Report Date
- November 6, 2013
- Manufacturer
- G.A. SURGICAL (PVT) LTD.
- Product Code
- HFX
- PMA / PMN Number
- K043533
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEROYAL: THE SUPPLIER OF THIS DEVICE DETERMINED THAT THE ROOT CAUSE WAS NEGLIGENCE OF THE QC DURING FINAL INSPECTION AND PACKING. THE QC HAS BEEN REPLACED WITH A WELL-TRAINED EMPLOYEE AND STRICT INSTRUCTION WAS ISSUED TO FOLLOW ALL GUIDELINES. THE CUSTOMER HAS BEEN SENT A REPLACEMENT.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT THERE WAS EXCESIVE BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633589 | DEROYAL | HFX - CLAMP, CIRCUMCISION | HFX | G.A. SURGICAL (PVT) LTD. | 33423747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |