FDA Adverse Event
Other
Summary report: N
11X100MM KII NON-THR SHIELDED BLADED ACCESS SYSTEM
MDR report key: 1633225
·
Received March 15, 2010
Report
- Report Number
- 2027111-2010-00030
- Event Type
- Other
- Date Received
- March 15, 2010
- Date of Event
- February 23, 2010
- Report Date
- March 9, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
EVENT PRODUCT IS NOT RETURNING. ANOTHER DEVICE FROM THE SAME LOT NUMBER WILL BE RETURNED AND EVALUATED. FOLLOW UP WILL BE SENT WITH ADDITIONAL INFO.
Description of Event or Problem · 1
"PHARMACIST REPORTS THAT SEVERE BLEEDINGS OCCUR AFTER THE TROCAR IS INTRODUCED. CUSTOMER REPORTS THAT THIS IS THE SECOND TIME THIS INCIDENT HAPPENED SINCE THEY USE THIS MODEL. BLEEDING AT THE SITE OF THE PORT HAVE BEEN REPORTED. THEY HAD TO RE-OPERATE THE PT TO STOP THE BLEEDING AT THE SITE OF THE PORT. THE PT RECOVERED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 11X100MM KII NON-THR SHIELDED BLADED ACCESS SYSTEM | NONE | GCJ | APPLIED MEDICAL RESOURCES | C0R62 | 1101656 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |