FDA Adverse Event
Injury
Summary report: N
A.D. PROTRACTION FASKMASK
MDR report key: 8170567
·
Received December 17, 2018
Report
- Report Number
- 2016150-2018-00061
- Event Type
- Injury
- Date Received
- December 17, 2018
- Date of Event
- December 7, 2018
- Report Date
- April 30, 2019
- Manufacturer
- ORMCO CORPORATION
- Product Code
- DZB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IT WAS ALLEGED THAT A.D. PROTRACTION FACEMASK HAS MADE A PATIENT VERY ILL; HOWEVER, NO FURTHER SPECIFIC INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THIS TIME. UPON FURTHER INFORMATION RECEIVED WE WILL SEND AN UPDATE.
Additional Manufacturer Narrative · 1
IT WAS ALLEGED THAT A.D. PROTRACTION FACEMASK HAS MADE A PATIENT VERY ILL; HOWEVER NO FURTHER SPECIFIC INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THIS TIME. UPON FURTHER INFORMATION RECEIVED WE WILL SEND AN UPDATE.
Description of Event or Problem · 1
IT IS ALLEGED THAT A.D. PROTRACTION FACEMASK HAS MADE A PATIENT VERY ILL.
Description of Event or Problem · 1
IT IS ALLEGED THAT A.D. PROTRACTION FACEMASK HAS MADE A PATIENT VERY ILL.
Description of Event or Problem · 1
IT IS ALLEGED THAT A.D. PROTRACTION FASKMASK HAS MADE A PATIENT VERY ILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1008010 | A.D. PROTRACTION FASKMASK | A.D. PROTRACTION FASKMASK | DZB | ORMCO CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |