MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2020-01-19 for PUREWICK FEMALE EXTERNAL PWF030F manufactured by C.r. Bard, Inc. (covington) -1018233.
[175882690]
The reported event was inconclusive, as the device was not returned for evaluation. However, the potential root cause for this reported event could be user related (eg: unhygienic condition, exposure to environment for a long time) or mechanical error (eg: sterile barrier issue). 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. 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 nd 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. "
Patient Sequence No: 1, Text Type: N, H10
[175882691]
It was reported that the patient experienced a uti with use of the wick. The patient's doctor suggested she no longer use the device. It was unknown what interventions were given for the uti.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00418 |
| MDR Report Key | 9604936 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-01-19 |
| Date of Report | 2020-01-19 |
| Date Mfgr Received | 2019-12-26 |
| Date Added to Maude | 2020-01-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUREWICK FEMALE EXTERNAL |
| Generic Name | WICK |
| Product Code | NZU |
| Date Received | 2020-01-19 |
| Catalog Number | PWF030F |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-19 |