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Catalog Number 70PH
Device Problems Disconnection (1171); Suction Problem (2170)
Patient Problems Skin Irritation (2076); Skin Tears (2516)
Event Type  malfunction  
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 Description
It was reported that the purewick patient tubing disconnected from the purewick device; therefore, the purewick patient tubing allegedly suctioned to the patient's skin for an entire night.The patient allegedly experienced a blister and the home nurse was called to shave and clean the patient 's blister.
Event Description
It was reported that the purewick patient tubing disconnected from the purewick device; therefore, the purewick patient tubing allegedly suctioned to the patient's skin for an entire night.The patient allegedly experienced a blister and the home nurse was called to shave and clean the patient 's blister.
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 state the following: "purewick user guide us patent no.8,287,508 © 2017 purewick corporation fda registration: 3012224959 www.Purewick.Com external catheter system for women trusted by hospitals and nurses nationwide welcome congratulations on your purchase of the purewick® external catheter system for women.The soft and flexible purewick external catheter is designed to capture up to 100% of urine and provides a sanitary, effective and efficient alternative to internal catheters.Save these instructions read all operating instructions, safety information, and warning notices before first use of this product.For more information, including video tutorials, visit www.Purewick.Com.Table of contents page specifications 2 safety 3 unpack and setup 4 wick placement and removal 6 cleaning and maintenance 8 frequently asked questions 10 troubleshooting 12 replacement and accessory items 14 customer support and warranty 15 specifications ac input voltage: 100¿120vac operating environment ac frequency: 60hz temperature: 50°f¿95°f (10°c¿35°c) ac connector: iec320 c7 relative humidity: 5¿70%, non-condensing product does not cause and is unaffected by electromagnetic interference u.S.Patent no.8,287,508 fda registration: 3012224959 2 safety cautions and warnings ¿ the purewick external catheter system is for external use only.Never insert wick into vagina, anal canal, or other body cavities.¿ do not use wick with bedpan or other impermeable material.¿ this product contains dry natural rubber and may cause an allergic reaction in users sensitive to latex.¿ if rash, irritation, discomfort or symptom of allergy occurs, immediately stop using the purewick system.¿ always unplug drydoc vacuum station¿ (¿drydoc¿) prior to cleaning exterior and when not in use.¿ do not immerse drydoc in water.Should drydoc fall into water, unplug unit before retrieving.¿ if drydoc drops or tips, unplug the unit and thoroughly inspect for loose or damaged parts before resuming use.Contact customer support if damage is observed or service is required.¿ the 16¿ vacuum hose connecting drydoc to collection jar may occasionally collect a light vapor.This is not unusual and does not affect function.However, if urine or water has streamed into the pump, discontinue use and contact customer support.¿ empty urine from collection jar regularly to prevent overflow.Failure to empty canister before urine overflow may cause damage to dry doc and is not covered under warranty.3 unpack and setup ¿ inspect the shipping box for damage.If damage is noticed, contact purewick immediately.Carefully remove the unit and all contents, including the packing material, from the shipping container.¿ place the purewick drydoc vacuum station (a) next to the bed or chair where it will be used.It must be close enough for the 70¿ patient hose (b) to easily reach the user.Avoid creating a tripping hazard with the patient hose.¿ plug the drydoc power cord into an electrical outlet.If an extension cord is used, make sure it does not create a tripping hazard.¿ place the collection jar (c) in the drydoc well and press down firmly on the lid.Attach the 16¿ vacuum hose (d) to the drydoc connector port (e) and the drydoc unit and to the connector port labeled ¿vacuum¿ (f) on the collection jar lid.¿ attach the 70¿ patient hose (b) to the connector port labeled ¿patient¿ (g) on the collection jar lid.Connect the other end of the 70¿ patient hose securely to wick (h).¿ turn on the drydoc by pressing the on/off switch on top of the drydoc.The drydoc vacuum station is functioning when the switch glows and the pump makes a soft humming sound.The purewick system is now ready for use.4 a drydoc vacuum station b 70¿ patient hose c collection jar with lid d 16¿ vacuum hose e drydoc connector port f vacuum connector port g patient connector port h wick 5 wick placement and removal purewick users can be lying on back or side, or seated on a padded chair.1.Remove wick from its package.2.Attach wick to patient hose.Check to ensure all system hose connections are secure.3.Turn on drydoc vacuum station.4.Hold wick with hose connector upward and gauze (white) side facing the user's perineum.5.Gently separate gluteus muscles and labia.6.Align upper gauze (white) portion of wick against pubic bone.7.Gently tuck soft gauze side between separated gluteus and labia.Wick should fit snugly against the body.8.To remove wick, gently separate gluteus muscles and labia and remove wick away from patient (never slide up or down).¿ discard and replace wick at least once every 8-12 hours and when soiled.Users who experience irritation should replace wicks after each urination or discontinue use if irritation continues.¿ empty urine from collection jar regularly to prevent overflow.¿ never insert wick into vagina, anal canal or other body cavities.6 tips for success: ¿ careful wick placement and removal prevents irritation.Gently place and remove wick toward or away from patient with a horizontal motion.Never slide, pull or push wick up or down through the perineum to avoid discomfort or abrasion.¿ if using wick overnight, proper positioning can be maintained using underwear or mesh underwear to help hold wick in place.Wick placement varies with individual anatomy.Adjust placement as necessary to find the best position for success ¿ it may take several attempts.Users can typically capture 100% of urine after establishing positioning technique.¿ incorrectly positioned wicks may cause urine leakage onto clothing or bedding.Using a diaper or use an incontinence pad can capture leaks.7 cleaning and maintenance cleaning collection jar and hoses the collection jar and patient hose should be cleaned daily as follows: ¿ discard used wick and disconnect hoses from collection jar lid.¿ remove collection jar lid, and empty urine from collection jar.¿ reattach lid to collection jar and reconnect both hoses to lid.¿ turn on the drydoc and place end of patient hose in a container of clean water.Allow water to flow through patient hose and into collection jar for 10-15 seconds.Never run water through vacuum hose attached to the drydoc.¿ turn off the drydoc.Disconnect both hoses from collection jar lid and remove lid.Pour contents into a toilet.¿ separately rinse collection jar and lid in a sink with mild soapy water.Rinse thoroughly.¿ replace lid on collection jar and reconnect both hoses.¿ without daily cleaning, urine residue may build up in patient hose.If a film begins to form, follow the above cleaning procedure every 3-5 days using a solution of ¿ c vinegar and 1 c water.¿ replace collection jar, lid and both hoses monthly.¿ wicks cannot be cleaned or reused and should be discarded after 8 to 12 hours and when soiled to minimize the chance of irritation or infection.8 cleaning the drydoc vacuum system unplug the drydoc prior to cleaning.Use a soft cloth with a mild solution of soap and water or a neutral detergent (like dishwashing soap) to gently wipe the exterior surfaces of the drydoc.Do not immerse the drydoc in water.Do not use solvents (such as thinner, alcohol, ether, etc.) on the drydoc.Improper cleaning may damage components and impair performance.Internal components never need cleaning.Care and maintenance of the dry doc vacuum system in addition to regular cleaning, inspect the drydoc periodically for wear.Contact purewick for service, replacement parts and repair.Do not attempt to open or dismantle the drydoc.Tampering with the drydoc may affect performance, create a potential safety hazard, cause personal injury and void the warranty.Storage when the drydoc is not in use for an extended period, unplug power cord from its outlet and cover the drydoc to prevent dust buildup.9 frequently asked questions how often should the wick be changed? wicks should be changed every 8-12 hours and when soiled.Can purewick handle output from users on diuretics? yes.Purewick¿s collection rate of 500cc/20 seconds should be sufficient for users on diuretics.Those users could consider using the large collection jar (item 2000ccj).Can purewick be used when user is on her side or sitting in a chair? yes, purewick can be used when the user is lying or reclining on her back or side, as well as when seated in a chair.Users should have adequate cushioning when using purewick while sitting in a chair and care must be taken to ensure that the wick is not positioned beneath the coccyx.Will turning user dislodge the wick? the wick can be tucked back into place after the user is turned.If lying on her side, lift the user¿s leg before removing or repositioning the wick.Users need not lie still to keep the wick in place.Many can learn to re-tuck the wick themselves.Can users wear underwear? yes, users can wear underwear.In fact, netted or mesh underwear can help secure the wick, especially with very thin or frail users.Does using purewick impact mobility? no.Remove and set aside wick (may be wrapped in paper towel) to accommodate mobility.Reposition wick when the user has returned to bed or chair.10 what if the wick leaks? accurate positioning is key to preventing leaks.Place the wick snugly against the perineum, align top of white gauze against pubic bone, and tuck the end of the wick between the gluteus.After confirming proper positioning, check system vacuum function.Can the wick cause skin damage? can the tubing or its connection cause a pressure ulcer? there have been no reports of pressure or moisture associated ulcers from purewick.When removing the wick, be sure to properly spread the labia and gluteus before removing the wick to avoid skin abrasion.Users must not lie on the tubing.What if user has loose bowel movements? care should be taken to clean the perineum and replace soiled wicks after each loose bowel movement.Can purewick be used if user is menstruating? anything more than trace amounts of blood could clog the wick.Tampons may be used while using purewick; otherwise purewick use is not recommended during menstruation.Can purewick be used to collect a clean catch? what about output measurement? yes, purewick can be used to obtain a clean sample.Cleanse the perineum as with any clean catch, and use a new wick with new tubing and a new collection jar.Volume measurement markings on the collection jar provide accurate monitoring of urine output.How can i reorder wicks and accessories? call toll-free (844) 584-0734 or (619) 660-0734 or email info@purewick.Com to order replacement wicks and accessories.See page 14 for details.11 troubleshooting symptom check the following the drydoc vacuum system on/off switch does not glow when turned on check that the power cord is plugged into a functioning outlet.The user¿s skin, clothing, bedding or diaper is slightly damp check and reposition the wick.Wick placement varies with individual anatomy.Adjust placement as necessary to find the best position for success ¿ it may take several attempts.Positioning the wick snugly against the perineum and between labia and gluteus should prevent leaks.Users can typically capture 100% of urine after establishing positioning technique.Use an incontinence pad to protect bedding and furniture from minor leaks.The user¿s skin, clothing, bedding or diaper is soaking wet 1.Check to ensure drydoc vacuum system is turned on and plugged in to a functioning outlet.When on, the on/off switch glows and the system makes a humming sound.2.Be certain overflow stop valve in center of underside of collection jar lid is open.This valve stops the vacuum by floating up to the closed position when the collection jar is full.It also closes when the lid or jar is tipped sideways or upside down.Disconnect vacuum hose and gently shake the lid to reset the valve down to the open position.12 symptom check the following the user¿s skin, clothing, bedding or diaper is soaking wet (continued) 3.Check hose connections.Secure ends of vacuum hose and confirm that (shorter) vacuum hose is connected from vacuum port in center of collection jar lid to drydoc vacuum system.Confirm that (longer) patient hose is firmly connected from wick to patient port near edge of collection jar lid.4.Check (longer) patient hose for blockage.5.Check drydoc vacuum system.With both hoses attached to collection jar lid, turn on drydoc.If a wick is attached to the end of (longer) patient hose, remove wick and hold end of hose in a cup of water.The system should easily vacuum water into collection jar.If not, check collection jar lid to be certain it is sealed.6.If water easily flows into collection jar and the patient hose is not blocked, replace current wick and carefully reposition wick as described on page 6 ¿wick placement and removal.¿ a tutorial video is available at www.Purewick.Com.There are no user-serviceable parts in the drydoc vacuum system.Adjustments or modifications by anyone other than an authorized purewick representative will void the warranty (see page 15).13 replacement and accessory items item item number description wick 625 the purewick wick is a soft and flexible external catheter for women that wicks urine away to keep the body dry and odor free.Discard and replace at least once every 8-12 hours and when soiled.10¿x 1.5¿ 1200ccj replacement collection jar with lid.1200cc collection jar with lid 2000ccj large replacement collection jar with lid.2000cc urine privacy cover 200006 urine privacy cover - replace as needed.Slides up over collection jar like a coffee cup sleeve to block view of collected urine with a volume view window.8¿x 5¿ (pkg of 25) patient hose 70 inch 70ph 70 inch patient hose.Replace every 30 days.Vacuum hose 16 inch 16vh 16 inch vacuum hose.Replace every 30 days.Stand 601493 stand keeps drydoc elevated above floor or carpet for easy access to collection jar, satisfies local and national regulations (does not include drydoc).14.5¿x 14.5¿x 10.5¿; 4.9 lbs.14 customer support toll free: (844) 584-0734 purewick corporation phone: (619) 660-0734 2030 gillespie way, suite 109 fax: (619) 660-5459 el cajon, ca 92020 email: info@purewick.Com www.Purewick.Com drydoc vacuum station¿ limited warranty purewick corporation (¿purewick¿) warrants the drydoc vacuum station against defects in material and workmanship when used as instructed in this guide for three (3) years from the date of shipment.This limited warranty applies only to the original purchaser of the equipment.This warranty does not apply to accessories and consumable parts or to damage caused by abuse, misuse, ordinary and cosmetic wear and tear, failure to follow directions, improper maintenance, adjustments or modifications by anyone other than an authorized purewick representative.The liability of purewick, under valid warranty claims, is limited to repair or replacement at purewick¿s facility or elsewhere, at the option of purewick.The foregoing limited warranty is exclusive and in lieu of all other warranties, whether written, oral, or implied, and shall be purchaser¿s sole remedy and purewick ¿s sole liability under contract or warranty or otherwise for the product.Purewick disclaims any implied warranty of merchantability or fitness for particular purposes.In no event shall purewick be liable for any incidental or consequential damages, including lost profits, or injury arising out of or in connection with the use or performance of the product delivered hereunder.15".
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Brand Name
Type of Device
Manufacturer (Section D)
203 gillespie way
el cajon CA 92020
MDR Report Key7639628
MDR Text Key112557791
Report Number1018233-2018-02429
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741151811
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 07/12/2018
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
Device Operator Lay User/Patient
Device Catalogue Number70PH
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/04/2018
Initial Date FDA Received06/26/2018
Supplement Dates Manufacturer Received07/05/2018
Supplement Dates FDA Received07/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age99 YR