MAUDE Adverse Event Report: PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL

Catalog Number	PWF030
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); Skin Irritation (2076); Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient allegedly experienced a deep tissue injury in the right perianal area 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), rn.
Additional 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 or Problem Description
It was reported that the patient allegedly experienced a deep tissue injury in the right perianal area 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.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Common Device Name: PUREWICK FEMALE EXTERNAL
• Manufacturer (Section D): PUREWICK CORPORATION ¿ 3012224959; 203 gillespie way; el cajon CA 92020
• MDR Report Key: 7930154
• Report Number: 1018233-2018-04570
• Device Sequence Number: 1764073
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR
• Patient Weight: 70