FDA Adverse Event
Other
Summary report: N
UNIVERSAL PENDULOUS SEAL
MDR report key: 851166
·
Received May 16, 2007
Report
- Report Number
- 2027111-2007-00030
- Event Type
- Other
- Date Received
- May 16, 2007
- Date of Event
- March 31, 2007
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- HET
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER. WHEN PRODUCT IS RECEIVED, EVALUATION WILL BE COMPLETED AND FINAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
"SMALL PORTION OF INNER SEAL BROKE OFF AND FELL INTO ABDOMEN - WAS RETRIEVED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL PENDULOUS SEAL | PENDULOUS SEAL | HET | APPLIED MEDICAL RESOURCES | C0600 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |