Catalog Number CLR222 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Seroma (2069); Not Applicable (3189)
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Event Date 06/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please explain what was the findings at the re-operation? initial procedure date.How was the patient treated when the prineo was removed? date that patient was brought back for re-suturing? reason that patient was brought back for re-suturing? is the event related to wound dehiscence? how was the seroma treated? please indicate what medical or surgical interventions were performed? what is the physicians opinion of the contributing factors to the event? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender.Patient pre-existing medical conditions.Additional information was requested and the following was obtained: this error occurred due to an absence of ward nurse education.They were a new user of the product.
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Event Description
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It was reported that a patient underwent a knee surgery on an unknown date and topical skin adhesive was used.Post operatively, the topical skin adhesive was inadvertently removed after only 2 days.The nurse reports that there appeared to a substantial seroma formation under the topical skin adhesive.The patient returned to the operating theater to have the knee re-sutured subcuticularly with continuous technique.Additional information has been requested.
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Manufacturer Narrative
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Product complaint # pc-(b)(4).Date sent to fda: (b)(4) 2018.Additional information was requested and the following was obtained: what is the physicians opinion of the contributing factors to the event? the doctor does not have any issues with prineo.He is looking to continue evaluating the product.The doctor was disappointed with the ward nurse not being familiar with the post op management of the product.Also, the floor co-ordinator wasn¿t familiar and gave incorrect advice to remove the product.This was the issue.Training has been provided to ensure that all new team members are captured and competent in their awareness of prineo¿s capability.
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Search Alerts/Recalls
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