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

Lot Number 1000107291

Device Problem Material Rupture (1546)

Patient Problem Pregnancy (3193)

Event Date 11/15/2017

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 reporter did not specify the variety of durex that was used.The reporter also neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis.Further information is expected.The product labelling also states that "no method of contraception can give you 100% protection against pregnancy".The company's assessment is non-serious with a relatedness of possible.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 company's assessment is serious with a relatedness of possible.

Event Description

Patient stated that the pregnancy was extrauterine [ectopic pregnancy], condoms broke and now the girl was pregnant [pregnancy with contraceptive device], condoms broke [device breakage].Case description: initial report, received date: 29-nov-2017.Received from consumer relations, country: (b)(6), (b)(4).Suspect product: durex unknown condoms.Batch no.And expiry date: not provided.(b)(4), is a spontaneous case report sent by a consumer which refers to a female age unknown.The case was received from (b)(6).It was reported by the patient's partner that on an unknown date, his girlfriend used the durex unknown condoms, frequency, route, indication, and stop date were all unknown.Reporter stated that condoms broke and now the girl was pregnant.At the time of reporting action taken with the suspect product not applicable and outcome of the case was unknown.No further information was available at the time of report.Case assessment for durex unknown condoms 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 possible and unknown.Case outcome: unknown.The case has been linked to (b)(4) due to the same reporter.Non-significant follow up.Received date: 07-dec-2017.Received from consumer relations, country: (b)(6), (b)(4).Non-significant update: reporter stated that the patient was upset and the results of the factory did not help him in any way because the partner was already pregnant.Report no 2, received date: 12-dec-2017.Received from consumer relations, country: (b)(6), (b)(4).Information added/ updated: the case has been upgraded from non-serious to serious.As reported suspect product: updated from "durex unknown condoms" to "durex invisible unknown condoms".Batch no.: "1000107291"added.Expiry date: "01-dec-2020" added.Event: "extrauterine pregnancy" added.Product start date: (b)(6) 2017" added.Company diagnosis: updated from "condom failure pregnancy" to "extrauterine pregnancy".Reporter stated that the pregnancy was extra uterine.It was also reported that the sexual intercourse happened last month (b)(6) 2017), the breakage was noticed at the end of the sexual intercourse and the partner did not administer second day pill.Reporter stated that she had only one sexual intercourse during last month (b)(6) 2017) with the partner and she discovered to be pregnant.Her partner went to the doctor and got the confirmation of an extra uterine pregnancy that was interrupted from evolution, using some pills recommended by the doctor.At the time of reporting action taken with the suspect product not applicable and outcome of the case was 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: 7298174
• MDR Text Key: 101003265
• Report Number: 3008559248-2018-00002
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2020
• Device Lot Number: 1000107291
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2017
• 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