inforMED
InjuryDZB

A.D. PROTRACTION FASKMASK

Received Dec 17, 2018 · Event occurred Dec 7, 2018

Report 2016150-2018-00061 · MDR key 8170567

Device

Generic name

A.d. Protraction Faskmask

Manufacturer

Ormco Corporation

Catalog number

716-0001

Product problems

  • Patient-Device Incompatibility

Patient

Not reported

  • Complaint, Ill-Defined
  • Complaint, Ill-Defined

Narrative

Additional Manufacturer Narrative

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

IT IS ALLEGED THAT A.D. PROTRACTION FACEMASK HAS MADE A PATIENT VERY ILL.

Additional Manufacturer Narrative

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

IT IS ALLEGED THAT A.D. PROTRACTION FACEMASK HAS MADE A PATIENT VERY ILL.

Description of Event or Problem

IT IS ALLEGED THAT A.D. PROTRACTION FASKMASK HAS MADE A PATIENT VERY ILL.