FDA Adverse Event Other Summary report: N

MIST THERAPY SYSTEM

MDR report key: 736785 · Received July 17, 2006

Report

Report Number: 3004580659-2006-00004
Event Type: Other
Date Received: July 17, 2006
Date of Event: June 21, 2006
Manufacturer: CELLERATION, INC.
Product Code: NRB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

ADD'L INFO RECEIVED FROM PT ON 7/14/2006: PT CONTINUED TO HAVE RED AND ITCHY EYES OVER THE NEXT WEEK DUE TO ALLERGIC REACTIONS FROM THREE DIFFERENT ANTIBIOTIC EYE DROPS SHE WAS GIVEN FROM OCCUPATIONAL HEALTH, E.R., AND HER ALLERGIST. HER ALLERGIST FELT AS THOUGH THE REACTIONS SHE WAS EXPERIENCING WERE DUE TO ONE OF THE COMPONENTS OF THE ANTIBIOTIC DROPS, AND UNRELATED TO THE INCIDENT IN THIS REPORT.

Description of Event or Problem · 1

PHYSICIAN THERAPIST (PT) TREATING A WOUND WAS ACCIDENTALLY SPRAYED IN THE FACE. PT EXPERIENCED BLOODSHOT EYES AND A SPLOTCHY FACE FOLLOWING THE EVENT. AT THE TIME OF THE EVENT, THE PT HAD HER FACE AS CLOSE TO THE SURFACE OF THE WOUND AS POSSIBLE WITHOUT ANY PROTECTIVE EQUIPMENT (SUCH AS A MASK OR GOGGLES) IN ORDER TO ENSURE THAT THE TIP OF THE DEVICE'S PLASTIC APPLICATOR DID NOT COME IN CONTACT WITH THE SURFACE OF THE PT'S WOUND. THE PT HAS A HISTORY OF MULTIPLE ALLERGIES. THE MFR'S INSTRUCTIONS FOR USE STATE THAT THE USER OF THE DEVICE SOULD FOLLOW APPROPRIATE INFECTION CONTROL PROCEDURES WHILE ADMINISTERING TREATMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MIST THERAPY SYSTEM	*	NRB	CELLERATION, INC.	CP-8004	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other