MAUDE Adverse Event Report: IDS MANUFACTURING CO,.LTD LIFESTYLES SILKY SMOOTH PERSONAL LUBRICANT

Lot Number 16100104DR

Device Problem Cross Reactivity (1137)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2017 - tested factory retain samples, checked dhr/production records and also tested the returned sample (unused from stock).All test results showed no abnormality and all were within product release specifications.Lubricant also contains no banana or orange extract.No root cause was identifiable and could be due to user's existing sensitivities.No further action can be taken at this time.The reporting of this event was due to a us equivalent product available in the us (lifestyles 2 in 1 personal lubricant).No similar events have been reported to date in the us market for this product.

Event Description

On (b)(6) 2017 incident occured in (b)(6) with an (b)(4) product variant.Customer states that partner has had two incidents of reaction after using ansell lifestyles silky smooth lubricant.The first reaction was "stinging pain" that went away after a couple of days.The second reaction caused very intense stinging pain requiring the partner to go to the hospital for treatment.She was treated for an allergic reaction (medication prescribed unknown) and she was released after 5-6 hours.

Manufacturer Narrative

(b)(6) 2017 - tested factory retain samples, checked dhr/production records and also tested the returned sample (unused from stock).All test results showed no abnormality and all were within product release specifications.Lubricant also contains no banana or orange extract.No root cause was identifiable and could be due to user's existing sensitivities.No further action can be taken at this time.The reporting of this event was due to a us equivalent product available in the us (lifestyles 2 in 1 personal lubricant).No similar events have been reported to date in the us market for this product.(b)(6) 2017 factory retain samples tested, dhr/production records check, and testing of returned samples.All results and reports showed no abnormality and product was manufactured in specification without deviation.No identifiable root cause could be done with respect to the incident.No further investigation can be made and the event is closed.

Event Description

(b)(6) 2017 incident occured in (b)(6) with an (b)(6) product variant.Customer states that partner has had two incidents of reaction after using ansell lifestyles silky smooth lubricant.The first reaction was "stinging pain" that went away after a couple of days.The second reaction caused very intense stinging pain requiring the partner to go to the hospital for treatment.She was treated for an allergic reaction (medication prescribed unknown) and she was released after 5-6 hours.

• Brand Name: LIFESTYLES SILKY SMOOTH PERSONAL LUBRICANT
• Type of Device: PERSONAL LUBRICANT
• Manufacturer (Section D): IDS MANUFACTURING CO,.LTD; 21/7 liabkwangsong; village no 6; lamlukka pathum thani, 12130 ; TH 12130
• MDR Report Key: 6447390
• MDR Text Key: 71323039
• Report Number: 1019632-2017-00006
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2017,07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2020
• Device Lot Number: 16100104DR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2017
• Distributor Facility Aware Date: 02/22/2017
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 03/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR