Based on the available information, this event is deemed to be a reportable malfunction and serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: (b)(4).
|
The end user reported that in an unknown number of pouches from unknown number of market units with unknown lot numbers, the mass was disintegrating, exposing a thin, clear plastic film.He changed every 4 days.He stated that near the end of wearing it for the 4th day, he experienced laceration and bleeding that he attributed to this while on blood thinners.The end user believed that when the plastic was being exposed with the smaller wafer size, it was causing trauma when he had to make a sudden change in position.The end user was unable to give the date of occurrence for the injury.He did not seek medical attention for the bleeding event.The end user was using 1-1/8" wafer with irregular shaped stoma and level of protrusion fluctuated at times.No photo is available at this time.
|