57 results
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36ms
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Sources: EU EUDAMED, US FDA
PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the body through a PVC tube via a continuous, low pressure vacuum pump (PureWick DryDoc) or to a hospital wall vacuum. There is never a reversal of flow direction or static state of fluid between the device and the patient. Also, the dry natural rubber component is double wrapped with 75D polyester and it is not stretched in its application to expose bare rubber to a user. The Wick does not enter the vagina (Figure 1).
FDA Recall
Terminated
·Purewick Corporation·Product code NNW·February 24, 2016
PUREWICK PATIENT TUBING
FDA Adverse Event
Malfunction
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·June 26, 2018
PUREWICK FEMALE EXTERNAL
FDA Adverse Event
Malfunction
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·August 6, 2018
PUREWICK DRYDOC STATION
FDA Adverse Event
Malfunction
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·July 30, 2018
PUREWICK FEMALE EXTERNAL CATHETER
FDA Adverse Event
Malfunction
·PUREWICK CORPORATION ¿ 3012224959·Product code NNW·October 26, 2017
PUREWICK FEMALE EXTERNAL.
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·November 11, 2018
PUREWICK FEMALE EXTERNAL CATHETER
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·December 5, 2018
PUREWICK FEMALE EXTERNAL
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·October 3, 2018
PUREWICK FEMALE EXTERNAL.
FDA Adverse Event
Malfunction
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·November 29, 2018
PUREWICK FEMALE EXTERNAL.
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·November 20, 2018
PUREWICK FEMALE EXTERNAL
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·October 3, 2018
PUREWICK FEMALE EXTERNAL
FDA Adverse Event
Malfunction
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·December 26, 2018
PUREWICK FEMALE EXTERNAL.
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·October 1, 2018
PUREWICK FEMALE EXTERNAL
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·May 9, 2019
PUREWICK DRY DOC STATION
FDA Adverse Event
Malfunction
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·April 8, 2019
PUREWICK FEMALE EXTERNAL CATHETER
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·May 2, 2019
PUREWICK FEMALE EXTERNAL
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·May 8, 2019
PUREWICK FEMALE EXTERNAL CATHETER
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·June 11, 2019
PUREWICK FEMALE EXTERNAL CATHETER
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·June 19, 2019
PUREWICK FEMALE EXTERNAL
FDA Adverse Event
Injury
·PUREWICK CORPORATION ¿ 3012224959·Product code NZU·April 29, 2019