MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT LIMITED DUREX; CONDOM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident.The patient did specify the variety of durex that was used as durex natural feeling condoms.The patient neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis.Further information is expected.The company's assessment is serious with a relatedness of possible.

Event Description

Case description: initial report, received date: 09-mar-2019.Received from consumer relations, country: (b)(6), reference no: (b)(4).Medical device: durex natural feeling condoms.Batch no and expiry date: not provided.Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a male age unknown.It was reported that on an unknown date, a male patient of an unknown age used durex natural feeling condoms for an unknown indication.Patient reported that on unknown date, product had caused the allergic reaction.Patient stated that usage of the condom lead to an emergency stay in the hospital.The patient was admitted to the hospital, admittance date, discharge date, days in hospital were all unknown.The case was deemed serious because it was classed as medically significant due to hypersensitivity and hospitalisation.Follow up has been requested to obtain further information.The company's assessment is serious with a relatedness of possible and unanticipated.Case outcome: unknown.

• Brand Name: DUREX
• Type of Device: CONDOM
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: joanne martinez ; dansom lane; hull, HU8 7-DS ; UK HU8 7DS
• MDR Report Key: 8476142
• MDR Text Key: 140734040
• Report Number: 3003071219-2019-00003
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• PMA/PMN Number: K072169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other