FDA Adverse Event
Other
Summary report: N
COLLAGEN PLUG - HELIPLUG
MDR report key: 1709361
·
Received June 1, 2010
Report
- Report Number
- 2523190-2010-00003
- Event Type
- Other
- Date Received
- June 1, 2010
- Date of Event
- April 9, 2010
- Report Date
- June 1, 2010
- Manufacturer
- MILTEX, INC.
- Product Code
- EKR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WHO HAD A HELIPLUG APPLIED POST EXTRACTION TO SOCKET #30 HAD SYMPTOMS OF DIFFICULTY SWALLOWING AND SOME DIFFICULTY BREATHING WITHIN 24 HOURS OF THE SOCKET DRESSING APPLICATION. THE PRODUCT WAS REMOVED 4 OR 5 DAYS AFTER THE PROCEDURE AND THE PT HAD NO FURTHER SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLAGEN PLUG - HELIPLUG | M54 - ORAL SURGERY | EKR | MILTEX, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |