FDA Adverse Event
Injury
Summary report: N
DISPOSABLE CLIP APPLIER CARTRIDGE
MDR report key: 852953
·
Received May 21, 2007
Report
- Report Number
- 2027111-2007-00039
- Event Type
- Injury
- Date Received
- May 21, 2007
- Date of Event
- April 15, 2007
- Report Date
- May 18, 2007
- Manufacturer
- APPLIED MEDICAL RESOURCES CORP.
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION. IF PRODUCT IS RETURNED, EVALUATION WILL BE COMPLETED AND FINAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
"DOCTOR SAID REPLACED CLIPS (2) ON CYSTIC DUCT STUMP; PT CAME BACK INTO OR WITH IN 24 HOURS WITH A STUMP LEAK. HAD TO RE-CLIP THE DUCT STUMP. HE SAID CLIPS REBOUNDED OFF THE DUCT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE CLIP APPLIER CARTRIDGE | NONE | GDO | APPLIED MEDICAL RESOURCES CORP. | CA001 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization |