FDA Adverse Event Other Summary report: N

FORM FIT HYDROGEL CANALICULAR PLUGS

MDR report key: 1204823 · Received October 20, 2008

Report

Report Number: 2083373-2008-00002
Event Type: Other
Date Received: October 20, 2008
Date of Event: September 18, 2008
Report Date: October 17, 2008
Manufacturer: OASIS MEDICAL, INC.
Product Code: LZU
PMA / PMN Number: K040912
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF BATCH PRODUCTION AND STERILIZATION RECORDS SHOWS THAT THERE WERE NO REMARKABLE EVENTS, ANOMALIES OR NONCONFORMANCE'S DURING PRODUCTION OF FORM FIT HYDROGEL CANALICULAR PLUG, REFERENCE LOT NUMBER LH1006C. A TOTAL OF 2,016 FORM FIT HYDROGEL CANALICULAR PLUGS, FROM LOT NUMBER LH1006C HAVE BEEN DISTRIBUTED. THIS IS THE ONLY CUSTOMER WHO HAS REPORTED ANY ADVERSE EVENTS. CONCLUSION: AS A RESULT OF INVESTIGATION RESULTS, OASIS MEDICAL CANNOT DEFINITIVELY DETERMINE THAT FORM FIT HYDROGEL CANALICULAR PLUG LOT NUMBER LH1006C WAS DIRECTLY OR INDIRECTLY RESPONSIBLE FOR THE REPORTED OBSERVATION OF CANALICULITIS. ISSUES HAVE BEEN RESOLVED AT THIS TIME FOR THE PT.

Description of Event or Problem · 1

AS REPORTED BY A DR, A PT DEVELOPED CANALICULITIS AFTER INSERTION OF AN OASIS MEDICAL, INC. FORM FIT HYDROGEL CANALICULAR PLUG. REPORTED OBSERVATION: PT DEVELOPED CANALICULITIS ON THE RIGHT UPPER LID AFTER INSERTION OF AN OASIS MEDICAL, INC. FORM FIT HYDROGEL CANALICULAR PLUG. PRODUCT LOT NUMBER: LH1006C. PRODUCT INSERTED IN 2007. DATE OF COMPLICATION: 2008. REPORTED TO OASIS MEDICAL, INC., ON 09/18/2008.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FORM FIT HYDROGEL CANALICULAR PLUGS	INTRACANALICULAR PLUG	LZU	OASIS MEDICAL, INC.	6303	LH1006C

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention