Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPAN PACKAGING SERVICES D.B.A. MULTI PACK SOLUTION LIFESTYLES EXCITE GEL; PERSONAL LUBRICANT
  • 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
 

SPAN PACKAGING SERVICES D.B.A. MULTI PACK SOLUTION LIFESTYLES EXCITE GEL; PERSONAL LUBRICANT Back to Search Results
Device Problem Cross Reactivity (1137)
Patient Problem Reaction (2414)
Event Date 09/23/2016
Event Type  Injury  
Manufacturer Narrative
The 510k 021125.
 
Event Description
After a report of (b)(6) from end user, ansell followed up to end user to get additional information on a product complaint.On (b)(6), end user indicated that they developed a rash after using the product.The end user consulted with a physician who indicated to use an over the counter product such as vaseline and hydrocortisone cream.
 
Manufacturer Narrative
On (b)(6) 2016 customer did not retain product and could not provide a lot/batch number for ansell to check batch record information.No other adverse reports of this type have been reported to date.
 
Event Description
After a report of (b)(6) from end user, ansell followed up to end user to get additional information on a product complaint.On (b)(6), end user indicated that they developed a rash after using the product.The end user consulted with a physician who indicated to use an over the counter product such as vasoline and hydrocortinsone cream.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIFESTYLES EXCITE GEL
Type of Device
PERSONAL LUBRICANT
Manufacturer (Section D)
SPAN PACKAGING SERVICES D.B.A. MULTI PACK SOLUTION
4611-a dairy drive
greenville SC 29607
MDR Report Key5995176
MDR Text Key56331804
Report Number1019632-2016-00009
Device Sequence Number1
Product Code NUC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/03/2016,10/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/03/2016
Distributor Facility Aware Date09/23/2016
Device Age1 YR
Event Location Home
Date Report to Manufacturer10/03/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age18 YR
-
-