MAUDE Adverse Event Report: SSL MANUFACTURING (THAILAND) LTD. DUREX - UNSPECIFIED; CONDOM, SYNTHETIC

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.The patient did not specify the variety of durex that was used.The patient also neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis.Therefore, the company is unable to conduct any further investigation at this moment in time.Further information is expected.Use a condom only once.Store in a cool dry place away from direct sunlight.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 is serious with a relatedness of possible.

Event Description

Condom torn at least twice this year and it caused patient to get sexually transmitted disease [sexually transmitted disease].Condom torn at least twice this year [device breakage].Case description: initial report, received date: 17-aug-2016.Received from consumer relations, country: (b)(6).Suspect product: durex unspecified condom.Batch no and expiry date: not provided.Case reference number (b)(4) 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 condom, frequency, route, indication, stop date and duration were all unknown.Patient stated that the condom torn at least twice this year (??-???-2016) and it had caused her to get a sexually transmitted disease (std) on ??-???-2016; she also had to take the morning after pill several times.She stated that she thinks the product was unsafe, as she had torn condoms several times over the years.At the time of report, outcome of event was unknown.The case was deemed serious because it was classed as medically significant due to sexually transmitted disease.No further information was available at the time of report.Case assessment for durex unspecified 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 possible and unknown.Case outcome: unknown.This case is linked to (b)(4) due to same reporter.

• Brand Name: DUREX - UNSPECIFIED
• Type of Device: CONDOM, SYNTHETIC
• Manufacturer (Section D): SSL MANUFACTURING (THAILAND) LTD.; wellgrow industrial estate; 100 moo 5, bangna-trad km 36; bangsamak, banpakong, chachoengsao 24180 ; TH 24180
• 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 ; 4042478
• MDR Report Key: 6042721
• MDR Text Key: 57985103
• Report Number: 3003071219-2016-00002
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• 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
• Date Manufacturer Received: 08/17/2016
• 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