MAUDE Adverse Event Report: PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL; DRY DOC MACHINE

Catalog Number	DD15
Medical Device Problem Code	Increase in Suction (1604)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the dry doc device suction was to strong and caused the patient some pain and discomfort.
Event or Problem Description
It was reported that the dry doc device suction was to strong and caused the patient some pain and discomfort.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause of the reported event could be that the user did not follow procedure for establishing suction due to which the suction was too high, resulting in patient impact, pain and discomfort.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¿ fec with a bedpan or any material that does not allow for sufficient airflow.¿ to avoid potential skin injury, never push or pull the purewick¿ fec against the skin during placement or removal.¿ never insert the purewick¿ fec 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¿ fec ¿ 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¿ fec.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¿ fec.¿ maintain suction until the purewick¿ fec is fully removed from the patient to avoid urine backflow." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Common Device Name: DRY DOC MACHINE
• Manufacturer (Section D): PUREWICK CORPORATION ¿ 3012224959; 203 gillespie way; el cajon CA 92020
• MDR Report Key: 8964704
• Report Number: 1018233-2019-05381
• Device Sequence Number: 11402984
• Product Code: NZU
• UDI-Device Identifier: 00801741151781
• UDI-Public: (01)00801741151781
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DD15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1