MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DRY DOC MACHINE

Catalog Number	DD15
Medical Device Problem Code	Increase in Suction (1604)
Health Effect - Clinical Codes	Abrasion (1689); 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¿s been having problems with the purewick.She said there are spots of blood on the wick, her labia feels abraded and sore, and it feels like the wick is suctioning on her labia, pinching it.She has spoken with her doctor about this.No medical intervention reported.Per follow up on (b)(6) 2020, the customer felt like the suction was higher on the dry doc, she has now switched to silicone wicks.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 this failure would most likely not be caused by the user.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 said she¿s been having problems with the purewick.She said there are spots of blood on the wick, her labia feels abraded and sore, and it feels like the wick is suctioning on her labia, pinching it.She has spoken with her doctor about this.No medical intervention reported.Per follow up on 21jan2020, the customer felt like the suction was higher on the dry doc, she has now switched to silicone wicks.No medical intervention reported.

• Brand Name: DRY DOC MACHINE
• Common Device Name: DRY DOC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9654832
• Report Number: 1018233-2020-00707
• Device Sequence Number: 2511382
• 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): 03/23/2020

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: Lay User/Patient
• Device Catalogue Number: DD15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1