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

Catalog Number	PWF030F
Health Effect - Clinical Codes	Abrasion (1689); Irritation (1941)
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 stated the machine was just suctioning air and caused irritation.It also caused sores in her vaginal area.She thought it was a combination of the urine and the rubber which caused the irritation.She stated she avoided using the machine due to this.The patient also stated the patient hose kept popping of.It was unknown if the patient received intervention for the sores.
Event or Problem Description
It was reported that the patient stated the machine was just suctioning air and caused irritation.It also caused sores in her vaginal area.She thought it was a combination of the urine and the rubber which caused the irritation.She stated she avoided using the machine due to this.The patient also stated the patient hose kept popping of.It was unknown if the patient received intervention for the sores.
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.The device was not returned.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Common Device Name: PURE WICK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9712493
• Report Number: 1018233-2020-01066
• Device Sequence Number: 2475186
• Product Code: NZU
• UDI-Device Identifier: 00801741163081
• UDI-Public: (01)00801741163081
• 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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: PWF030F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/14/2020
• 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
• Outcome Attributed to Adverse Event: Other