MAUDE Adverse Event Report: PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL

Catalog Number	PWF030
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Skin Discoloration (2074); Ulcer (2274); Pressure Sores (2326)
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 information provided by bard 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 bard.The device was not returned.
Event or Problem Description
It was reported that the patient experienced a stage ii pressure ulcer to the perianal skin and labia bilaterally.The skin was assessed and the catheter was changed at least once a shift (q12hr), and more frequently when stooling.Redness was noted the morning of (b)(6) (day#6), subsequently, the catheter was removed.A skin care rn was consulted, who noted the skin injury occurred to the perianal skin and labia bilaterally, which mirrored where the rigid part of the purewick catheter that was in contact with the skin.The use of the purewick catheter was discontinued and the use of incontinence pads resumed.Once removed, the skin was monitored, however no dressing interventions were done.The purewick recommendations were to 'replace every 8-12 hours or if soiled with feces or blood.Assess skin for compromise and perform perinal care prior to placement of a new purewick femal external catheter.'the purewick recommendations were followed, however further review of purewick materials recommended q2hr removal of the device and skin assessment, which was not done for this patient.It was later reported that the suction was set to 60mmhg while in use.No medical intervention reported.
Additional Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.
Event or Problem Description
It was reported that the patient experienced a stage ii pressure ulcer to the perianal skin and labia bilaterally.The skin was assessed and the catheter was changed at least once a shift (q12hr), and more frequently when stooling.Redness was noted the morning of 6/6 (day#6), subsequently, the catheter was removed.A skin care rn was consulted, who noted the skin injury occurred to the perianal skin and labia bilaterally, which mirrored where the rigid part of the purewick catheter that was in contact with the skin.The use of the purewick catheter was discontinued and the use of incontinence pads resumed.Once removed, the skin was monitored, however no dressing interventions were done.The purewick recommendations were to 'replace every 8-12 hours or if soiled with feces or blood.Assess skin for compromise and perform perinal care prior to placement of a new purewick femal external catheter.'the purewick recommendations were followed, however further review of purewick materials recommended q2hr removal of the device and skin assessment, which was not done for this patient.It was later reported that the suction was set to 60mmhg while in use.No medical intervention reported.

• Brand Name: PUREWICK FEMALE EXTERNAL
• Common Device Name: PUREWICK
• Manufacturer (Section D): PUREWICK CORPORATION ¿ 3012224959; 203 gillespie way; el cajon CA 92020
• MDR Report Key: 7645243
• Report Number: 1018233-2018-02458
• Device Sequence Number: 1582270
• Product Code: NZU
• UDI-Device Identifier: 00801741143083
• UDI-Public: (01)00801741143083
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2018

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: Health Professional
• Device Catalogue Number: PWF030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/16/2018
• 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
• Patient Age: 81 YR
• Patient Weight: 91