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

Catalog Number DD15

Device Problems Increase in Suction (1604); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)

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 experienced bleeding allegedly as a result of the suction on the dry doc being too strong.No medical intervention was reported.

Event Description

It was reported that the patient experienced bleeding allegedly as a result of the suction on the dry doc being too strong.No medical intervention was reported.

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: ¿1.Connect the canister to wall suction and set to a minimum of 40mmhg continuous suction.Always use the minimum amount of suction necessary.If using the drydoctm vacuum station, connect the canister to the unit and turn the unit on.Please consult the drydoctm vacuum station user guide for further information.2.Using standard suction tubing, connect the purewicktm female external catheter to the collection canister.Peri-care and placement: 3.Perform perineal care and assess skin integrity (document per hospital protocol).Separate legs, gluteus muscles, and labia.Palpate pubic bone as anatomical marker.4.With soft gauze side facing patient, align distal end of the purewicktm female external catheter at gluteal cleft.Gently tuck soft gauze side between separated gluteus and labia.Ensure that the top of the gauze is aligned with the pubic bone.Slowly place legs back together once the purewicktm female external catheter is positioned.Note: patient can be positioned on back, side lying, frog legged, or lying on back with knees bent and thighs apart (lithotomy position) prior to device placement.Removal: 5.To remove the purewicktm female external catheter, fully separate the legs, gluteus, and labia.To avoid potential skin injury upon removal, gently pull the purewicktm female external catheter directly outward.Ensure suction is maintained while removing the purewicktm female external catheter.After use, this product may be a potential biohazard.Dispose of in accordance with applicable local, state and federal laws and regulations.Maintenance: 6.Replace the purewicktm female external catheter at least every 8-12 hours or if soiled with feces or blood.Always assess skin for compromise and perform perineal care prior to placement of a new purewicktm female external catheter." 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 FEMALE EXTERNAL
• Type of Device: PUREWICK DRYDOC STATION
• Manufacturer (Section D): PUREWICK CORPORATION ¿ 3012224959; 203 gillespie way; el cajon CA 92020
• MDR Report Key: 8655996
• MDR Text Key: 146641178
• Report Number: 1018233-2019-02839
• Device Sequence Number: 1
• Product Code: NZU
• UDI-Device Identifier: 00801741151781
• UDI-Public: (01)00801741151781
• 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,distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: DD15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1