FDA Adverse Event
Other
Summary report: N
SCHEIN HEDSTRM 25MM SZ 25
MDR report key: 2222547
·
Received August 5, 2011
Report
- Report Number
- 2523190-2011-00055
- Event Type
- Other
- Date Received
- August 5, 2011
- Report Date
- August 5, 2011
- Manufacturer
- INTEGRA, YORK - IMILTEX
- Product Code
- EKS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTS THAT THE FILE TIPS ARE BREAKING UPON INSERTING INTO THE CANAL AS WELL AS WHEN PUTTING THE RUBBER STOP ON THE FILE. THIS IS A NEW FILE RIGHT FROM THE BOX. THE FILES BREAK IN THE TOOTH CANAL AND THE PATIENT WAS SENT TO AN ENDODONTIC. DEVICE DISCARDED BY CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCHEIN HEDSTRM 25MM SZ 25 | M50 - ENDODONTICS | EKS | INTEGRA, YORK - IMILTEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |