MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT. LIMITED DUREX PERFORMAX INTENSE CONDOM (USA) / DUREX EXTENDED PLEASURE CONDOM (INDIA)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Gangrene (1873); Hypersensitivity/Allergic reaction (1907); Pain (1994); Peeling (1999); Rash (2033); Skin Discoloration (2074)

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 condom that was used.The patient also did not provide 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.The company's assessment is serious with a relatedness of probable.

Event Description

Superficial penile skin gangrene [gangrene], allergic contact dermatitis [dermatitis contact], swelling [swelling], pain [pain], sloughing [skin exfoliation], vesicle eruption [rash vesicular], patchy blackening of penile skin [rash], patchy blackening of penile skin [skin discolouration].Case description: initial report, received date: 25-oct-2018.Received from literature, country: (b)(6).Suspect product: benzocaine extended-pleasure unknown condom.Batch no and expiry date: not provided.Case reference number (b)(4) is a literature case report sent by a physician which refers to a male (b)(6).It was reported by a physician that on an unknown date, a (b)(6) male patient used benzocaine extended-pleasure unknown condom, indication, dose, frequency, route, stop date and duration were all unknown.It was stated that patient was non-atopic, non-diabetic and presented with complaints of swelling, pain and patchy blackening of penile skin for the last 3 days.Patient stated that for improving the duration of sexual intercourse and for better sexual performance, he recently used a new brand of condom, which contained 5% benzocaine.He however denied the use of any lubricants or topical substance at the time of sexual act.There was no history of fever, inguinal or scrotal swelling, genital trauma, insect bite, known drug allergy, substance abuse or similar complaints in the past.In the past, he was using non-medicated natural rubber latex condom for contraception without any adverse effects.Following local examination revealed vesicle eruption, sloughing and patchy blackening of penile skin extending from prepuce to base of penis with a clear demarcation line with non-palpable inguinal lymph nodes suggestive of allergic contact dermatitis.The underlying tunica albuginea, corpora cavernosa and corpora spongiosa were not involved.His routine blood / urine examination and screening work-up for sexually transmitted diseases was unremarkable.Swab culture from penile lesion showed growth of group a beta-haemolytic streptococcus (s.Pyogenes).The patient was managed with culture-specific parenteral antibiotics and multiple sessions of surgical debridement.After 3 weeks of treatment, healthy pink granulating penile bed was achieved, after which a meshed, split-thickness skin grafting was performed under anaesthesia.The postoperative period was uneventful.The graft dressing was changed on the fifth postoperative day and it revealed a 100% take of the graft.Dermatology consultation was also taken and european baseline patch test series (including benzocaine, fragrance mix and nickel sulphate) was performed.The patch test showed positive patch reactions to benzocaine (5%) at 48 hours, at 72 hours and 96 hours.However, sensitivity to other performed allergens was negative.It was informed that at 6 months of follow-up, patient was doing fine with no sexual or urinary complaints.At the time of report, action taken with the suspect product was unknown and case outcome was recovered.The case was deemed serious because it was classed as medically significant due to gangrene.No further information was available at the time of report.Follow up has been requested to obtain further information.Case assessment of benzocaine extended-pleasure unknown 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 probable and unknown.Case outcome: recovered / resolved.

• Brand Name: DUREX PERFORMAX INTENSE CONDOM (USA) / DUREX EXTENDED PLEASURE CONDOM (INDIA)
• Type of Device: CONDOM
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT. LIMITED; dansom lane; hull, united kingdom HU8 7 DS; UK HU8 7DS
• Manufacturer (Section G): RECKITT BENCKISER HEATHCARE INT. LIMITED; dansom lane; hull, united kingdom HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: joanne martinez ; dansom lane; hull, united kingdom HU8 7-DS ; UK HU8 7DS
• MDR Report Key: 8075942
• MDR Text Key: 127348783
• Report Number: 3003071219-2018-00012
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K020659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR