MAUDE Adverse Event Report: SURETEX PROPHYLACTICS (I), LTD. SKYN; POLYISOPRENE LATEX MALE CONDOM

Lot Number 1706P30622

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 01/03/2018

Event Type  Injury  

Manufacturer Narrative

Customer experienced severe vaginal irritation necessitating trips to the doctor.Customer also states that there was a perfume smell to the condom.

Event Description

On (b)(6) 2018 customer experienced severe vaginal irritation necessitating trips to the doctor.Customer also states that there was a perfume smell to the condom.

Manufacturer Narrative

Customer experienced severe vaginal irritation necessitating trips to the doctor.Customer also states that there was a perfume smell to the condom.On 01/12/2018 - a review of the device history record indicated no deviation or out of specification result from the batch record.Retain samples from the same lot were evaluated for odor.No substantial mal odor was detected.No further assignable cause can be identified from the batch record.On 04/14/2018 - (b)(4) intact pieces sent back to the manufacturer.Testing os samples for odor met requirements.Testing for microbial evaluation for microbial count and total yeast and mold were below limit and test for 5 bacteria showed absence.No root cause can be attributed and with the original investigation, all performance and release criteria met specification.No further action to be taken.

Event Description

(b)(6) 2018 customer experienced severe vaginal irritation necessitating trips to the doctor.Customer also states that there was a perfume smell to the condom.

Manufacturer Narrative

Customer experienced severe vaginal irritation necessitating trips to the doctor.Customer also states that there was a perfume smell to the condom.On 01/12/2018, a review of the device history record indicated no deviation or out of specification result from the batch record.Retain samples from the same lot were evaluated for odor.No substantial mal odor was detected.No further assignable cause can be identified from the batch record.

Event Description

On (b)(6) 2018 customer experienced severe vaginal irritation necessitating trips to the doctor.Customer also states that there was a perfume smell to the condom.

• Brand Name: SKYN
• Type of Device: POLYISOPRENE LATEX MALE CONDOM
• Manufacturer (Section D): SURETEX PROPHYLACTICS (I), LTD.; 74-91 kiadb industrial estate; jigani ii phase,anekal taluk; bangalore karnataka, in-ka 560 1 05; IN 560 105
• MDR Report Key: 7168223
• MDR Text Key: 96501172
• Report Number: 3013388459-2018-00002
• Device Sequence Number: 1
• Product Code: MOL
• 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: 01/12/2018,04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1706P30622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2018
• Distributor Facility Aware Date: 01/03/2018
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 01/12/2018
• 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