FDA Adverse Event
Injury
Summary report: N
MEDACTA BIPOLAR HEAD 28/53
MDR report key: 3674027
·
Received February 10, 2014
Report
- Report Number
- 3005180920-2014-00006
- Event Type
- Injury
- Date Received
- February 10, 2014
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- KWY
- PMA / PMN Number
- K091967
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: BIPOLAR HEAD 28/53MM: REF. 25060.2853 / LOT 102238 (3 ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. ALL THE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.
Description of Event or Problem · 1
REFERENCE IMP# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86608 | MEDACTA BIPOLAR HEAD 28/53 | BIPOLAR HEAD | KWY | MEDACTA INTERNATIONAL SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |