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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL CATHETER
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PUREWICK CORPORATION ¿ 3012224959 PUREWICK FEMALE EXTERNAL CATHETER Back to Search Results
Catalog Number PWF030
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Urinary Tract Infection (2120); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the patient developed an allergic reaction and a severe urinary tract infection (uti) while using the latex wicks.The patient was reportedly prescribed bactrim and ciprofloxacin to treat the uti and was on nightly peritoneal dialysis.The patient reportedly discontinued use of the latex wicks.
 
Event Description
It was reported that the patient developed an allergic reaction and a severe urinary tract infection (uti) while using the latex wicks.The patient was reportedly prescribed bactrim and ciprofloxacin to treat the uti and was on nightly peritoneal dialysis.The patient reportedly discontinued use of the latex wicks.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential root cause of the reported event could be that the materials of construction were not biocompatible with the patient due to which there was an allergic reaction, resulting in severe uti.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: "not recommended for use on patients with a known latex allergy." 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.
 
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Brand Name
PUREWICK FEMALE EXTERNAL CATHETER
Type of Device
PUREWICK FEMALE EXTERNAL
Manufacturer (Section D)
PUREWICK CORPORATION ¿ 3012224959
203 gillespie way
el cajon CA 92020
MDR Report Key8575561
MDR Text Key143932730
Report Number1018233-2019-02295
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741143083
UDI-Public(01)00801741143083
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 07/03/2019
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
Device Operator Other
Device Catalogue NumberPWF030
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/12/2019
Initial Date FDA Received05/02/2019
Supplement Dates Manufacturer Received06/14/2019
Supplement Dates FDA Received07/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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