MAUDE Adverse Event Report: SURETEX PROPHYLACTICS (I), LTD LIFESTYLES; NATURAL RUBBER LATEX CONDOM

Lot Number 1601181922

Device Problem Cross Reactivity (1137)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/10/2017

Event Type  Injury  

Manufacturer Narrative

On 02/16/2017 a first review of release record indicates that the device met all specifications for release.Further evaluation on going.

Event Description

On (b)(6) 2017 user indicated that they received product from a public health service administered by the state of (b)(6).After using a lifestyles ultra lubricated latex condom, the user experienced contact dermatitis reaction.He later went to a dermatologist who provided a topical ointment treatment.User has communicated that they went to a allergist, conducted a patch test and showed allergy to me-isthiazolinone and parabens but not latex allergy; a copy of a report has not been provided to ansell.

Manufacturer Narrative

On (b)(6) 2017 a first review of release record indicates that the device met all specifications for release.Further evaluation on going (b)(6) 2017 13 pcs of same lot product were tested for microbial testing.Results are all within required specifications.No assignable cause can be found from a review of the dhr and inspection of retained samples.No further investigation or correction action identified.

Event Description

On (b)(6) 2017 user indicated that they received product form a public health service administered by the state of (b)(4).After using a lifestyles ultra lubricated latex condom, the user experienced contact dermatitis reaction.He later went to a dermatologist who provided a topical ointment treatment.User has communicated that they went to a allergist, conducted a patch test and showed allergy to me-isthiazolinone and parabens but not latex allergy; a copy of a report has not been provided to ansell.

Manufacturer Narrative

On 02/16/2017 a first review of release record indicates that the device met all specifications for release.Further evaluation on going.On 2/21/2017 13 pcs of same lot product were tested for microbial testing.Results are all within required specifications.No assignable cause can be found from a review of the dhr and inspection of retained samples.No further investigation or correction action identified on 03/30/2017 retain samples went through microbial testing; results were within specification.Customer samples were received and sent for microbial testing; results were within specification.No other action to be taken at this time.

Event Description

On 02/16/2017 user indicated that they received product form a public health service administered by the state of (b)(4).After using a lifestyles ultra lubricated latex condom, the user experienced contact dermatitis reaction.He later went to a dermatologist who provided a topical ointment treatment.User has communicated that they went to a allergist, conducted a patch test and showed allergy to me-isothiazolinone and parabens but not latex allergy; a copy of a report has not been provided to ansell.

• Brand Name: LIFESTYLES
• Type of Device: NATURAL RUBBER LATEX CONDOM
• Manufacturer (Section D): SURETEX PROPHYLACTICS (I), LTD; 74-91 kiadb estate; jigani ii phase, anekal taluk; bangalore karnataka, bangalore 56210 6; IN 562106
• MDR Report Key: 6336950
• MDR Text Key: 67646922
• Report Number: 1019632-2017-00004
• Device Sequence Number: 1
• Product Code: HIS
• 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,Followup
• Report Date: 02/16/2017

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: Lay User/Patient
• Device Expiration Date: 01/30/2021
• Device Lot Number: 1601181922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2017
• Distributor Facility Aware Date: 02/10/2017
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 02/16/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/21/2017; 03/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR