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

Device Problem Material Rupture (1546)

Patient Problem Ectopic Pregnancy (1819)

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 not specify the variety of product that was used.The patient neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis.No further information is expected; therefore, the company is unable to conduct any further investigation at this moment in time.The product labelling states that "no method of contraception can provide 100% protection against pregnancy or the transmission of hiv and stis.If you are worried that you or your partner may have become pregnant or infected, contact your doctor immediately." the company's assessment for this case is serious and possible.

Event Description

Ectopic pregnancy [ectopic pregnancy] fallopian tube ruptured [fallopian tube disorder] condom split [device breakage].Case description: initial report, received date: 22-jan-2018.Received from consumer relations, country: (b)(6), reference no: (b)(4).Suspect product: durex unspecified condoms.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 unspecified condoms for an unknown indication.Patient stated that on several occasions the condom had split.She stated that she took a contraception pill as well.Patient stated that on one occasion a split condom resulted in an ectopic pregnancy.Patient stated that she had not even contemplated being pregnant until she collapsed when fallopian tube ruptured.The case was deemed serious because it was classed as medically significant due to ectopic pregnancy.No further information was available at the time of report.Case assessment of durex unspecified condoms is as follows: the reported assessment has not been provided, case relatedness is possible.The company's assessment is serious with a relatedness of possible and unknown.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 (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: 7268922
• MDR Text Key: 99983451
• Report Number: 3003071219-2018-00001
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Other