C.R. BARD, INC. (COVINGTON) -1018233 SPIRIT® HYDROCOLLOID ADHESIVE SHEATH; MALE EXTERNAL CATHETER
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Model Number 39302 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2022 |
Event Type
malfunction
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Event Description
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It was reported that the patient had issues on removing adhesive male external catheters, they had to take a shower and use soap for removal.The representative let caregiver to know there are condom catheter with less adhesive area, warm water was recommended to help remove.The patient could also use adhesive remove that would be an item and they also have natural catheters.As per follow up via phone on 16nov2022, it was reported that the customer has a hard time in removing the catheters after use.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 device was not returned.
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Manufacturer Narrative
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The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "operator error".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "1) verify correct size prior to use.2) trim pubic hair if necessary.3) wash penis with mild soap and warm water.Dry thoroughly.Wear time may be reduced if skin is not dry or cream/oil is used.4) open package at perforation.Remove catheter from plastic insert, if present.5) place rolled end over the end of the penis, leaving a small space between the end of the penis and the cone of the catheter.6) unroll the catheter over penis.7) gently squeeze the catheter to properly seal adhesive to the skin.If possible, avoid leaving a rolled ¿collar¿ around the base of the penis.Important: wear time may be reduced if adhesive is not properly sealed to the skin.8) connect the catheter to a drainage system.Make sure to check that connections are secure before use.Directions to remove: 1) ensure drainage bag is empty.2) disconnect catheter from the drainage system.3) gently roll the catheter forward and off the penis.If necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive." h11: section a through f - 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.H3 other text : the device was not returned.
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Event Description
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It was reported that the patient had issues on removing adhesive male external catheters, they had to take a shower and use soap for removal.The representative let caregiver to know there are condom catheter with less adhesive area, warm water was recommended to help remove.The patient could also use adhesive remove that would be an item and they also have natural catheters.As per follow up via phone on 16nov2022, it was reported that the customer has a hard time in removing the catheters after use.No medical intervention was reported.
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Search Alerts/Recalls
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