FDA Adverse Event
Other
Summary report: N
BAG 4X6 10M 225ML VOL, MONARCH RETRIEVAL BAG
MDR report key: 819085
·
Received February 15, 2007
Report
- Report Number
- 2027111-2007-00003
- Event Type
- Other
- Date Received
- February 15, 2007
- Date of Event
- January 11, 2007
- Manufacturer
- APPLIED MEDICAL RESOURCES CORP.
- Product Code
- GCJ
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURE FOR EVALUATION. IF PRODUCT IS RETURNED, EVALUATION WILL BE COMPLETED AND FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
"SURGEON WAS PULLING OUT THE BAG WITH THE PATIENTS GALL BLADDER INSIDE AND THE BAG BROKE/RUPTURED AS HE WAS PULLING IT THROUGH THE ABDOMINAL WALL. HE HAD TO GET AN ETHICON BAG TO GET BOTH OUR BAG AND THE SPECIMEN OUT OF THE ABDOMEN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAG 4X6 10M 225ML VOL, MONARCH RETRIEVAL BAG | MONARCH RETRIEVAL BAG | GCJ | APPLIED MEDICAL RESOURCES CORP. | CD001 | 1025280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |