MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK FEMALE EXTERNAL

Catalog Number	PWF030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.The device was not returned.
Event or Problem Description
It was reported that the patient¿s son stated that his mom was not able to use the drydoc as the fecal matter kept plugging up the hoses.The hoses were changed several times, but the device still would not work.
Additional Manufacturer Narrative
Upon further review, bard/bd has determined that this mdr was initially reported in error as this event is not reportable.
Event or Problem Description
It was reported that the patient¿s son stated that his mom was not able to use the drydoc as the fecal matter kept plugging up the hoses.The hoses were changed several times, but the device still would not work.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d1, d2, d4.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.
Event or Problem Description
It was reported that the patient¿s son stated that his mom was not able to use the drydoc as the fecal matter kept plugging up the hoses.The hoses were changed several times, but the device still would not work.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Common Device Name: PUREWICK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9176543
• Report Number: 1018233-2019-06439
• Device Sequence Number: 2409511
• Product Code: NZU
• UDI-Device Identifier: 00801741151811
• UDI-Public: (01)00801741151811
• 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: Other,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2019

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: PWF030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 10/24/2019; 10/24/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 10/21/2019; 10/31/2019
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown