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

Device Problems Inadequate or Insufficient Training (1643); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2021

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 stated in commercials make it look easy, but when patient watched the video online it was not easy to use.Representative tried to explain they tried to make it as simple as possible with a little amount of components to use.Patient should watch the video and decide later and representative advised patient had he seen the video, but understand it was not for everyone.

Event Description

It was reported that the patient stated in commercials make it look easy, but when patient watched the video online it was not easy to use.Representative tried to explain they tried to make it as simple as possible with a little amount of components to use.Patient should watch the video and decide later and representative advised patient had he seen the video, but understand it was not for everyone.

Manufacturer Narrative

Per investigator evaluation, bd has determined that this mdr event is not reportable.H11: section a through f - the information provided by bd represents all 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 URINE COLLECTION SYSTEM STND (NON-BATTERY)
• Type of Device: UNKNOWN PUREWICK URINE COLLECTION SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12358952
• MDR Text Key: 267848752
• Report Number: 1018233-2021-05119
• Device Sequence Number: 1
• Product Code: NZU
• 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,other
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other