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

Lot Number B21A201810

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); 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 reporter was able to provide details of the product name, batch number and expiry date, 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".The company's assessment is serious with a relatedness of possible.

Event Description

Spontaneous miscarriage [abortion spontaneous].Patient had abundant bleeding [haemorrhage].Patient got pregnant [pregnancy with contraceptive device].Case description: initial report, received date: 30-mar-2018.Received from consumer relations, country: (b)(6), (b)(4).Suspect product: durex real condoms.Batch no: b21a201810.Expiry date: 01-oct-2018.(b)(4) is a spontaneous case report sent by a consumer which refers to a female age unknown.It was reported by the patient's husband that on an unknown date, his wife of an unknown age used the durex real condoms.Reporter stated that his wife got pregnant.She had abundant bleeding and they went directly to the hospital.Due to ovarian cysts it was even more complicated, doctors performed an operation, spontaneous miscarriage occurred.His wife still drinks antibiotics with regular monitoring of temperature and overall condition.Treatment had been reported but it was unclear which events were treated.The company's assessment is serious with a relatedness of possible and unanticipated.Case outcome: unknown.

• Brand Name: DUREX REAL FEEL KONDOMI
• 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; reckitt benckiser healthcare i; hull, HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: joanne martinez ; dansom lan; hull, HU8 7-DS ; UK HU8 7DS
• MDR Report Key: 7463240
• MDR Text Key: 106572447
• Report Number: 3003071219-2018-00004
• 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: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2018
• Device Lot Number: B21A201810
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA 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