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Catalog Number PWF030
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation.The potential root cause for this failure mode could be due to hypersensitivity to latex.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "indication for use: the purewick female external catheter is intended for non-invasive urine output management in female patients.Caution: this product contains dry natural rubber.Contraindications: patients with urinary retention.Warnings: do not use purewick female external catheter with bedpan or any material that does not allow for sufficient airflow.To avoid potential skin injury, never push or pull the purewick female external catheter against the skin during placement or removal, never insert the purewick female external catheter into vagina, and anal canal or other body cavities.Discontinue use if an allergic reaction occurs.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.Precautions: not recommended for patients who are: agitated, combative or uncooperative and might remove the purewick female external catheter.Having frequent episodes of bowel incontinence without a fecal management system in place.Experiencing skin irritation or breakdown at the site.Experiencing moderate/heavy menstruation and cannot use a tampon.Do not use barrier cream on the perineum when using the purewick female external catheter.Barrier cream may impede suction.Not recommended for use on patients who have undergone recent surgery of the external urogenital tract.Always assess skin for compromise and perform perineal care prior to placement of a new purewick female external catheter.Maintain suction until the purewick female external catheter is fully removed from he patient to avoid urine backflow.Recommendations:-perform each step with clean technique.N the home setting, wash hands thoroughly before device placement.Prior to connecting the purewick female external catheter to hospital wall suction tubing, verify suction function by covering the open end of the suction tubing with one hand and observing the pressure dial.If the pressure does not increase when the line is covered, verify that the tubing is secured, connected and not kinked.Ensure the purewick female external catheter remains in the correct position after turning the patient.Remove the purewick female external catheter prior to ambulation.Properly placing the purewick female external catheter snugly between the labia and gluteus holds the purewick female external catheter in place for most patients.Mesh underwear may be useful for securing the purewick female external catheter for some patients.Assess device placement and patient's skin at least every 2 hours.Replace the purewick 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." the device was not returned.
Event Description
It was reported that the patient had a skin related issue while using the purewick device.No medical intervention was reported.Per additional information received from the complainant via email on 23jul2019, the patient experienced what looked like a deep tissue injury per the certified wound care specialist.Per email received from the complainant on 30jul2019, the suction on the device was set to high (full) and that there was an extension set.
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Brand Name
Type of Device
Manufacturer (Section D)
203 gillespie way
el cajon CA 92020
Manufacturer (Section G)
203 gillespie way
el cajon CA 92020
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
MDR Report Key8893752
MDR Text Key154418585
Report Number1018233-2019-04698
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741143083
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPWF030
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/23/2019
Initial Date FDA Received08/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;