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

Catalog Number	DD15
Medical Device Problem Code	Increase in Suction (1604)
Health Effect - Clinical Codes	Pain (1994); No Consequences Or Impact To Patient (2199)
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 said she was getting sore spots, the suction was hurting her, and she was getting a pinching sensation.She said she used one wick for 24 hours, and the rep advised her it was recommended she change the wick after 8-12 hours of use.No medical intervention reported.
Event or Problem Description
It was reported that the patient said she was getting sore spots, the suction was hurting her, and she was getting a pinching sensation.She said she used one wick for 24 hours, and the rep advised her it was recommended she change the wick after 8-12 hours of use.No medical intervention reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.A labeling review was not completed as the user would not likely 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.H3 other text : the device was not returned.

• Brand Name: PUREWICK DRYDOCK STATION
• Common Device Name: DRYDOC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9474616
• Report Number: 1018233-2019-07985
• Device Sequence Number: 2602864
• Product Code: NZU
• UDI-Device Identifier: 00801741151781
• UDI-Public: (01)00801741151781
• 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): 01/16/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: DD15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1