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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL
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PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL Back to Search Results
Catalog Number PWF030
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Laceration(s) (1946); Skin Irritation (2076); Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.The device was not returned.
 
Event Description
It was reported that the patient allegedly experienced a deep tissue injury in the inner labia while using the purewick external catheter.The complainant stated that either calmoseptine or zinc oxide was used as treatment.Clinical statement: both calmoseptine and zinc oxide can be purchased over the counter.(b)(6).
 
Manufacturer Narrative
The device was not returned for evaluation.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: "warnings: ¿ do not use the 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, 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 with a known latex allergy.¿ proceed with caution in 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 the patient to avoid urine backflow.Recommendations: ¿ perform each step with clean technique.In 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.".
 
Event Description
It was reported that the patient allegedly experienced a deep tissue injury in the inner labia while using the purewick external catheter.The complainant stated that either calmoseptine or zinc oxide was used as treatment.Clinical statement: both calmoseptine and zinc oxide can be purchased over the counter.Tschlager, rn.
 
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Brand Name
PUREWICK FEMALE EXTERNAL
Type of Device
PUREWICK FEMALE EXTERNAL
Manufacturer (Section D)
PUREWICK CORPORATION ¿ 3012224959
203 gillespie way
el cajon CA 92020
MDR Report Key7930164
MDR Text Key122504506
Report Number1018233-2018-04561
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741143083
UDI-Public(01)00801741143083
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPWF030
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age84 YR
Patient Weight61
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