Model Number 39102 |
Device Problem
Incorrect Device Or Component Shipped (2962)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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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 bard represents all of 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 bard.
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Event Description
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It was reported that the complainant received a box for product catalog number 39102 with corporate lot number jubt1749; however, the product within the box was product catalog number 37104 with corporate lot number jubt1749.
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Manufacturer Narrative
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The reported issue was confirmed.The device was returned for evaluation.Visual inspection noted the printed product catalog was different in the box and individual packages.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿description/ indication: the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Precaution: do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Open package at perforation.To remove plastic insert, squeeze catheter at the top of the white cone and pull to release.Unroll self-adhering: catheter over penis.Gently squeeze the catheter to properly seal adhesive to the skin.Connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.Directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive." (b)(4).
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Event Description
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It was reported that the complainant received a box for product catalog number 39102 with corporate lot number jubt1749; however, the product within the box was product catalog number 37104 with corporate lot number jubt1749.
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Search Alerts/Recalls
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