FDA Adverse Event
Other
Summary report: N
BAG 4X6 10M 225ML VOL, MONARCH RETRIEVAL BAG
MDR report key: 1141356
·
Received August 28, 2008
Report
- Report Number
- 2027111-2008-00035
- Event Type
- Other
- Date Received
- August 28, 2008
- Date of Event
- July 28, 2008
- Report Date
- August 27, 2008
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EVENT SAMPLE WAS NOT RETURNED TO APPLIED; OUR INVESTIGATORS ARE CONTINUING TO EVALUATE THIS INCIDENT. A FOLLOW-UP REPORT WILL BE ISSUED UPON COMPLETION OF THEIR ANALYSIS.
Description of Event or Problem · 1
"PATIENT HAD PRIOR SURGERIES- MULTIPLE ADHESIONS- DOCTOR USED SAME INCISION SITE FOR TROCARS-DURING RETRIEVAL PROCESS THE BAG BROKE AND A FRAGMENT OF THE BAG WAS STUCK ON THE INCISION- THE FRAGMENT WAS LOST INSIDE OF THE PATIENT. AN INTERNAL INCIDENT REPORT WAS FILLED OUT WITH THE PRODUCT BEING SAVED (IN THE HOSPITAL). DR. TOOK FULL RESPONSIBILITY FOR INCIDENT."
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 | CD001 | 1064851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |