MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED DUREX ULTRA THIN FEEL CONDOM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anaphylactoid (2218); Reaction (2414)

Event Type  Other  

Event Description

Initial report received by (b)(6), date 06/11/2014, (b)(4).Medical device: durex ultra thin feel condom.Batch details: batch no.Unknown; expiry date: unknown.Reporter (physician) reported that a female consumer of unknown age developed anaphylaxis to durex ultra thin feel.The patient was not latex allergic, she was; however, milk allergic.Adverse event term: anaphylaxis, pt term: anaphylactic reaction.Outcome: unknown.The company's assessment for this case is possible and unanticipated.

Manufacturer Narrative

Manufacture narrative: reckitt benckiser is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident.The labeling states that the durex fetherlite ultra condoms are super fine with sensi-fit for even greater feeling.They are on average 20% thinner than our standard latex condoms while still providing a high level of security and protection.All our latex condoms exceed the iso4074: 2002 international quality standard for male natural rubber latex condoms.The company's assessment for this case is possible and unanticipated.Expected date of next report: 08/07/2014.No action considered necessary for this incident at this point, the company is currently waiting for follow up information regarding the reported incident.

• Brand Name: DUREX ULTRA THIN FEEL CONDOM
• Type of Device: CONDOM
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED; dansom lane; hull HU8 7DS; UK HU8 7DS
• Manufacturer (Section G): RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED; dansom lane; hull HU8 7DS; UK HU8 7DS
• Manufacturer Contact: morris corporate center iv; interpace pkwy, po box 255; parsippany, NJ 07054-0225
• MDR Report Key: 4146716
• MDR Text Key: 4768905
• Report Number: 3011015568-2014-00001
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 06/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1