MAUDE Adverse Event Report: PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL; PUREWICK DRYDOC STATION

Catalog Number	DD15
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Patient Problem/Medical Problem (2688)
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 patient developed an unknown injury to their mucosal membrane while using the purewick drydoc station.The patient was prescribed an unknown topical ointment.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿caution: it is important that the port connections be connected correctly for proper operation of the drydoc¿ vacuum station." 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 patient developed an unknown injury to their mucousal membrane while using the purewick drydoc station.The patient was prescribed an unknown topical ointment.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Common Device Name: PUREWICK DRYDOC STATION
• Manufacturer (Section D): PUREWICK CORPORATION ¿ 3012224959; 203 gillespie way; el cajon CA 92020
• MDR Report Key: 8775999
• Report Number: 1018233-2019-03787
• Device Sequence Number: 2413824
• Product Code: NZU
• UDI-Device Identifier: 00801741151781
• UDI-Public: (01)00801741151781
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DD15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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