FDA Adverse Event
Other
Summary report: N
12X100MM KII NON-THREADED FIOS FIRST ENTRY
MDR report key: 1490092
·
Received September 30, 2009
Report
- Report Number
- 2027111-2009-00106
- Event Type
- Other
- Date Received
- September 30, 2009
- Date of Event
- September 22, 2009
- Report Date
- September 29, 2009
- Manufacturer
- APPLIED MEDICAL RESOURCES CORP.
- Product Code
- GCJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT AND EVALUATION OF THE INCIDENT DEVICE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
"DR USED 12X100 FIOS FOR HIS FIRST STICK ON A GASTRIC BYPASS, AND UPON INSERTION OF THE DISTAL TIP OF THE OBTURATOR, HE HIT THE BOWEL CAUSING A MINOR INJURY, WHICH HE REPAIRED WITH A SUTURE. HE CONTINUED THE CASE WITHOUT INCIDENT. HE REPAIRED THE BOWEL INJURY WITH A SUTURE BUT THERE WAS NOT A "MALFUNCTION" OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12X100MM KII NON-THREADED FIOS FIRST ENTRY | NONE | GCJ | APPLIED MEDICAL RESOURCES CORP. | CFI73 | 1086630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |