Model Number PWFX30 |
Device Problem
Biocompatibility (2886)
|
Patient Problem
Hypersensitivity/Allergic reaction (1907)
|
Event Date 09/26/2022 |
Event Type
Injury
|
Event Description
|
It was reported that the customer got hives from mid-thigh to waist by using purewick female external catheter.The patient had allergies all their life, but they did not know that patient was allergic to silicone.It was stated that the patient saw a doctor and got benadryl and cortisone and advised to stop using.It was noted that the patient had been using this product for less than 90 days.
|
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd 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 bd.The device was not returned.
|
|
Manufacturer Narrative
|
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inadequate material selection - materials of construction are not biocompatible".It is 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 instructions for use were found adequate and state the following: "warnings: discontinue use if an allergic reaction occurs.Precautions: not recommended for patients who are: agitated, combative, or uncooperative and might remove the purewicktm female external catheter experiencing skin irritation or breakdown at the site"." recommendations: ensure the purewicktm female external catheter remains in the correct position after turning the patient.Remove the purewicktm female external catheter prior to ambulation.Properly placing the purewicktm female external catheter snugly between the labia and gluteus holds the purewicktm female external catheter in place for most patients.Mesh underwear may be useful for securing the purewicktm female external catheter for some patients.¿ assess device placement and patient¿s skin at least every 2 hours.¿ replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood.Change suction tubing per hospital protocol or at least every thirty (30) days".H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
|
|
Event Description
|
It was reported that the customer got hives from mid-thigh to waist by using purewick female external catheter.The patient had allergies all their life, but they did not know that patient was allergic to silicone.It was stated that the patient saw a doctor and got benadryl and cortisone and advised to stop using.It was noted that the patient had been using this product for less than 90 days.
|
|
Search Alerts/Recalls
|