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

Catalog Number	PWF030
Health Effect - Clinical Code	Ulcer (2274)
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 device was not returned.
Event or Problem Description
It was reported that the patient¿s mother stated the machine doesn't have enough suction and it was leaking during the night.She also stated she has positioned the wick herself, when her daughter was in the hospital, so she knows how to do it.Per additional information received on 15jan2020, the customer stated that they developed sores while using there purewick.It is currently unknown if the patient received medical intervention.
Additional Manufacturer Narrative
Upon further review, bard/bd medical has determined that this mdr was initially reported in error as this event is not reportable.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 mother stated the machine doesn't have enough suction and it was leaking during the night.She also stated she has positioned the wick herself, when her daughter was in the hospital, so she knows how to do it.Per additional information received on 15jan2020, the customer stated that they developed sores while using there purewick.It is currently unknown if the patient received medical intervention.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Common Device Name: PUREWICK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9654827
• Report Number: 1018233-2020-00705
• Device Sequence Number: 13922585
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• 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): 02/19/2020

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: Lay User/Patient
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1