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

Lot Number 1000232445

Device Problem Material Rupture (1546)

Patient Problems Miscarriage (1962); Pregnancy (3193)

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 product name, batch number 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 provide 100% protection against pregnancy or the transmission of hiv and stis." the company's assessment is serious with a relatedness of possible.

Event Description

Patient lost a baby after 8th weeks of pregnancy [abortion spontaneous].Condom broke during intercourse and patient got pregnant [pregnancy with contraceptive device].Condom broke during intercourse [device breakage].Case description: initial report, received date: (b)(6) 2018 received from consumer relations, country: (b)(6), reference no: (b)(4).Medical device: durex real feel condom.Batch no: 1000232445.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 real feel condom for an unknown indication.Patient stated that condom broke during intercourse and she got pregnant.Follow up has been requested to obtain further information.The company's assessment is non serious with a relatedness of possible and unanticipated.Case outcome: unknown.Report no 2, received date: (b)(6) 2018 received from consumer relations, country: (b)(6), reference no: (b)(4).Information added / updated: the case has been upgraded from non-serious to serious.Adverse event: "patient lost a baby after 8th weeks of pregnancy" was added.Company diagnosis: updated from "condom failure pregnancy" to "spontaneous abortion".Trimester of exposure: "first" was added.Patient stated that she lost a baby after eight weeks of pregnancy and she had to stay in the hospital, to check her body.At the time of reporting, action taken with the suspect product and case outcome were unknown.The patient was admitted to hospital, admittance date, discharge date and days in hospital were unknown.The case was deemed serious as it was classed as medically significant due to abortion spontaneous and hospitalization.Follow up has been requested to obtain further information.The company's assessment is serious with a relatedness of conditional and unanticipated.Case outcome: unknown.

• Brand Name: DUREX REAL FEEL
• Type of Device: DUREX REAL FEEL 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: 7844657
• MDR Text Key: 119151880
• Report Number: 3003071219-2018-00010
• Device Sequence Number: 1
• Product Code: MOL
• 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: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1000232445
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2018
• 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