MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM STND (NON-BATTERY); PURE WICK URINE COLLECTION SYSTEM

Catalog Number PW100

Device Problems Increase in Suction (1604); Suction Problem (2170)

Patient Problems Erythema (1840); Irritation (1941); Rash (2033); Skin Irritation (2076)

Event Type  malfunction  

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 Description

It was reported that the patient experienced redness, irritation and rash in vaginal area and was not sure that it was the suction or the wicks.It was reported that the doctor suggested the patient to stop using the product.No medical intervention reported.

Event Description

It was reported that the patient experienced redness, irritation and rash in vaginal area and was not sure that it was the suction or the wicks.It was reported that the doctor suggested the patient to stop using the product.No medical intervention reported.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.A potential root cause could be due to ¿inadequate component selection".The lot number is unknown therefore the device history record could not be reviewed.A labeling review was not completed as it is unlikely the user would cause this issue.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.

• Brand Name: PUREWICK URINE COLLECTION SYSTEM STND (NON-BATTERY)
• Type of Device: PURE WICK URINE COLLECTION SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10147965
• MDR Text Key: 195371565
• Report Number: 1018233-2020-03781
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741185342
• UDI-Public: (01)00801741185342
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: PW100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1