Model Number 413419 |
Device Problems
Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
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Patient Problems
Abrasion (1689); Hemorrhage/Bleeding (1888)
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Event Type
Injury
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Event Description
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This emdr has been submitted for one event only where silver nitrate was used.The end user reported that she had a granuloma from six to nine on her stoma which would bleed approximately one to two teaspoons intermittently with the company¿s product.She saw her local ostomy nurse, and she stated that she felt the product and friction, along with hernia which might contribute granuloma formation and resulted in the bleeding.Also stated consumer was not on blood thinners but bleeding resolved independently.Although, she stated that silver nitrate was used once on her stoma by her local ostomy nurse.And she also reported hernia and was waiting for a hernia belt and end user sometimes used to company¿s stoma belt.Consumer used to cut the moldable wafers to enlarge the opening.Her wear time was two to three days.Also reported that there was no leakage or skin irritation issues under wafer.No photo was available at this time.
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Manufacturer Narrative
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The event is considered as misuse.Per the information for use (ifu), a moldable ostomy device should not be cut.Age at time of event - 48 years.Based on the available information, this event is deemed to be a 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.Reporting site: 1049092 manufacturing site: 9618003.
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Manufacturer Narrative
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To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.
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Event Description
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To date no additional patient or event details have been received.
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Search Alerts/Recalls
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