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

Lot Number 1000274744

Device Problem Material Rupture (1546)

Patient Problem Venereal Disease (2071)

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.Upon reporting the incident the consumer was able to provide details of the batch number, product name and expiry date was not provided, therefore enabling rb to review the process records and release testing results from the point of initial manufacture and check retained samples for the specific batch identified.The product labelling also states that "no method of contraception can give you 100% protection against pregnancy, hiv or sexually transmitted infections.The company's assessment is serious with a relatedness of possible.

Event Description

Sexually transmitted disease [sexually transmitted disease].Product left at risk of pregnancy [pregnancy with contraceptive device] left approximately a quarter of the condom in situ [complication associated with device] condom broke during use [device breakage] case description: initial report, received date 25-apr-2018.Received from consumer relations, country (b)(6), reference no: (b)(4).Suspect product: durex thin feel batch no: 1000274744.Case reference number (b)(6) is a spontaneous case report sent by a consumer which refers to a female age unknown.It was reported that on an unknown date a female patient of an unknown age used durex thin feel condom, frequency, route, indication, stop date and duration were all unknown.Patient stated that a condom from lot 1000274744 broke during use and left approximately a quarter of the condom in situ resulting in a trip to her nurse to have this removed.Patient stated that the product had left her at risk of pregnancy and also std (sexually transmitted disease) which was the reason for use.Patient also stated that she had now been left exposed to a lifelong condition and have had to be prescribed antibiotics as well a second medication.This case has been deemed serious because it was classed as medically significant due to sexually transmitted disease and permanent impairment of a body function or permanent damage to a body structure.No further information was available at the time of report.Case assessment of durex thin feel condom is as follows: the reported serious assessment has not been provided, case relatedness is possible.The company's assessment is serious with a relatedness of probable and unknown.Case outcome: unknown.

• Brand Name: DUREX THIN FEEL
• Type of Device: CONDOM
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT. LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• Manufacturer (Section G): 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: 7535674
• MDR Text Key: 108975106
• Report Number: 3003071219-2018-00006
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• PMA/PMN Number: K980319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1000274744
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2018
• 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
• Patient Outcome(s): Other