MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT LIMITED DUREX INVISIBLE LUBRICATED LATEX CONDOMS; DUREX CONDOM

Lot Number 1000639826

Device Problem Material Fragmentation (1261)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Pelvic Inflammatory Disease (2000); Abnormal Vaginal Discharge (2123); Foreign Body In Patient (2687)

Event Date 10/01/2019

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 consumer 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

Initial report, received date 28-oct-2019.Received from consumer.Relations, (b)(6), (b)(4).Medical device: durex invisible extra lubricated condoms.Batch no: 1000639826.Expiry date: 31-oct-2023.Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a female (b)(6).It was reported that on (b)(6) 2019, a (b)(6) female patient used durex invisible extra lubricated condoms.Patient stated that two condoms broke during intercourse and she was very afraid because the condom was left in her and caused pelvic inflammatory disease.The first breakage was around (b)(6) 2019 and the piece of condom was inside the consumer until (b)(6) 2019.On (b)(6) 2019 patient went to the hospital due to mid-cycle bleeding, fluid from her vagina, vaginal pain and bladder pressure.Patient informed that she was advised by the doctor to take some antibiotics twice a day after she was diagnosed with the pelvic inflammatory disease.Patient reported that she stayed at the hospital for 6 hours to be treated.During the internal exam, doctor pulled out an approximately one-inch piece of the condom.She was treated for an infection with doxycycline and flagyl.Then again, she and her partner tried the condoms on (b)(6) 2019 and this time the tip of the condom broke off.The piece of the condom came out in her underwear and she was treated with an antibiotic shot.She stated that she had an intrauterine device.The case was deemed serious due to a condition necessitating medical or surgical intervention to prevent serious deterioration in health.Follow-up has been requested to obtain further information.The company's assessment is serious with a relatedness of possible and unanticipated.Case outcome: unknown.Case comment: reports assessment: diagnosis: pelvic inflammatory disease and vaginal infection.Event verbatim [preferred term] (related symptoms if any separated by commas); pelvic inflammatory disease [pelvic inflammatory disease]; vaginal infection [vaginal infection]; midcycle bleeding [metrorrhagia]; fluid from patient's vagina [vaginal discharge]; vaginal pain [vulvovaginal pain]; bladder pressure [bladder discomfort]; condom was left inside patient [foreign body in reproductive tract]; two condoms broke during intercourse / tip of the condom broke off [device breakage].

• Brand Name: DUREX INVISIBLE LUBRICATED LATEX CONDOMS
• Type of Device: DUREX 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, ; UK
• MDR Report Key: 9330370
• MDR Text Key: 183259366
• Report Number: 3008559248-2019-00009
• Device Sequence Number: 1
• Product Code: HIS
• UDI-Device Identifier: 00302340912778
• UDI-Public: 00302340912778
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Lot Number: 1000639826
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• 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; Required Intervention
• Patient Age: 31 YR