Catalog Number UNKNOWN |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Tissue Breakdown (2681); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/31/2022 |
Event Type
Injury
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Event Description
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It was reported that two of the patient experienced injury to penal area while using male external catheter.Both patients have complained of irritation and skin removal from the penal damage and pain.No medical intervention was reported.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Device was not returned.
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Event Description
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It was reported that two of the patient experienced injury to penal area while using male external catheter.Both patients have complained of irritation and skin removal from the penal damage and pain.It was unknown what medical intervention was provided.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿materials not biocompatible¿.It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device were unknown.Therefore, bd was unable to determine the associated labeling to review.Correction: b h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Search Alerts/Recalls
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