MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT. LIMITED DUREX SENSITIVO CONTACTO TOTAL(SPAIN), DUREX INVISIBLE CONDOM (USA); DUREX CONDOM

Lot Number 1000826152

Device Problem Material Fragmentation (1261)

Patient Problems Hot Flashes/Flushes (2153); Discomfort (2330); Foreign Body In Patient (2687)

Event Type  malfunction  

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 patient was not able to provide details of the product name but batch number and expiry date was 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 company's assessment is serious with a relatedness of possible.

Event Description

Case description: initial report.Received date 07-feb-2020.Received from consumer relations.Country: (b)(6).Reference no: (b)(4).Suspect product: durex sensitivo contacto total.Batch no: 1000826152.Expiry date: 01-jun-2024.Case reference number (b)(4) is a spontaneous case report sent by a consumer, which refers to a female patient of an unknown age.It was reported that on an unknown date, a female patient of an unknown age used durex sensitivo contacto total condom, frequency, indication, stop date and duration were all unknown.Patient stated that she had to go to the doctor as a piece of condom remained inside her after breaking during intercourse.Patient stated the doctor examined her in order to remove the broken piece but it was not successful.Patient explained the piece came out by itself 6 days later.Patient reported that she was waiting for a replacement intrauterine device, which is why she was using durex, she reported she was given emergency contraception which made her have constant body heat and sensitivity in her breasts.Patient also stated she had previously had an abortion and was allergic to one hormone that is all contraceptives which is why she trusted our product.At the time of report, the action taken with suspect product, and case outcome both were unknown.This case has been deemed serious due to a condition necessitating medical, or surgical intervention to prevent serious deterioration in health.No further information was available at the time of report.Follow up has been requested to obtain further information.Case assessment for durex sensitivo contacto total condom is as follows: the reporting consumer's serious assessment has not been provided, case relatedness is possible.The company's assessment is serious with a relatedness of possible and unlisted.Case outcome: unknown.A piece of condom remained inside the patient after breaking [foreign body]; condom broke [device breakage]; constant body heat [feeling hot]; sensitivity in breasts [breast discomfort].

• Brand Name: DUREX SENSITIVO CONTACTO TOTAL(SPAIN), DUREX INVISIBLE CONDOM (USA)
• Type of Device: DUREX CONDOM
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT. LIMITED; dansom lane; hull, united kingdom HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: joanne martinez ; dansom lane; hull, united kingdom ; 4042478
• MDR Report Key: 9765057
• MDR Text Key: 215117767
• Report Number: 3008559248-2020-00010
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K980319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 1000826152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other