FDA Adverse Event
Malfunction
Summary report: N
IMPLANT
MDR report key: 1962329
·
Received January 18, 2011
Report
- Report Number
- 2124215-2011-00897
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- December 28, 2010
- Report Date
- March 31, 2011
- Manufacturer
- VI
- Product Code
- DQY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS SUPPLEMENTAL IS BEING FILED TO UPDATE CODING OF PRODUCT ALLEGATION.
Additional Manufacturer Narrative · 1
THE PRODUCT WAS DISPOSED OF BY THE HOSPITAL. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS UNIVERSAL CUTTER, MODEL 7060, WAS PLANNED TO BE USED DURING A IMPLANT PROCEDURE INVOLVING THIS PATIENT. IT WAS SUSPECTED THAT THE PACKAGE STERILITY WAS POTENTIALLY BREACHED, THEREFORE, IT WAS NOT UTILIZED. THIS MODEL OF UNIVERSAL CUTTER WAS INCLUDED IN A PHYSICIAN COMMUNICATION DATED (B)(6), 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANT | CUTTER | DQY | VI | 7060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4) |