MAUDE Adverse Event Report: ANSELL/SURETEX/LIFESTYLES SKYN CONDOM; CONDOM, SYNTHETIC

Lot Number 2201P20522

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Scar Tissue (2060); Localized Skin Lesion (4542); Swelling/ Edema (4577)

Event Date 11/27/2022

Event Type  Injury  

Event Description

Lesions, bleedings, loss of upper epidermis, puss, swelling and scarring on my genital area after using skyn condoms.I have used this brand for many years.There are two batches of this product that have severe quality issues and are causing adverse side effects.Blood tests revealed no stis.Date to be confirmed.

Event Description

¿additional information received for report mw5115846 on 7/11/2023 to add lifestyles as the mfr.¿.

• Brand Name: SKYN CONDOM
• Type of Device: CONDOM, SYNTHETIC
• Manufacturer (Section D): ANSELL/SURETEX/LIFESTYLES; po box 57; stewartstown PA 17363
• MDR Report Key: 16573961
• MDR Text Key: 311704765
• Report Number: MW5115846
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 2201P20522
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian