• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PUREWICK CORPORATION ¿ 3012224959 : PUREWICK FEMALE EXTERNAL Back to Search Results
Catalog Number PWF030
Device Problems Increase in Suction (1604); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Patient Problems Bruise/Contusion (1754); Hematoma (1884); Hemorrhage/Bleeding (1888)
Event Type  Injury  
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 device was placed by the day shift nurse and at around 1930, the patient requested to use the bedside commode. The purewick was removed and replaced with a new one once the patient got back in the bed. The nurse stated that it was possible that the wick was not placed correctly between the labia and was placed resting on top of the labia. The nurse noted the suction on the device was set at "low continuous". Around 0300 the patient requested to use the bedside commode again, the purewick was removed and the nurse's aid noticed blood on the patient's legs and on the white absorbent pad portion of the purewick. The nurse's assessment allegedly found bleeding coming from a hematoma (presumably from being suctioned) and bruising along both sides of the patient's labia. The device was discontinued. Per the nurse, the total length of placement was approximately 14 hours, intermittently, due to removal for commode use. Nurse (b)(6) stated she felt that due to the patient's age with thinning skin that the device may not have been an appropriate choice. The device was used due to the patient having a lasix drip. The patient stated that she did not experience any pain. No medical intervention was reported. It was later reported by the complainant via email on (b)(6) 2018, that the patient reportedly did not have a latex allergy and the reported bleeding stopped on its own. The hematoma was reported to be approximately 5mm in diameter.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name: PUREWICK FEMALE EXTERNAL
Type of DevicePUREWICK FEMALE EXTERNAL
Manufacturer (Section D)
PUREWICK CORPORATION ¿ 3012224959
203 gillespie way
el cajon CA 92020
Manufacturer (Section G)
PUREWICK CORPORATION ¿ 3012224959
203 gillespie way
el cajon CA 92020
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7740256
MDR Text Key115727191
Report Number1018233-2018-03208
Device Sequence Number1
Product Code NZU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberPWF030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/01/2018 Patient Sequence Number: 0
-
-