MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-08-07 for DUREX ANILLO DE PLACER manufactured by Reckitt Benckiser Healthcare Int. Limited.
[116309647]
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's name, batch number, however expiry date was not 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 product labelling also states that misuse of a constriction ring may cause bruising, painful injury, or permanent damage to the penis. The company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[116309648]
Depression [depression], bleeding during and post defecation [rectal haemorrhage], patient started feeling pain / pain was more intense in testicles, anus and penis [genital pain], lack of penis sensitivity [hypoaesthesia], difficulty to keep it as well ejaculation problems [ejaculation disorder], decreased urine flow [urine flow decreased], flaccidity [hypotonia], patient started feeling discomfort from the lower abdomen to the penis, glans and perineum region. [discomfort]. Case description: initial report, date 10-jul-2018. Received from consumer relations, (b)(6), (b)(4). Suspect product: durex pleasure ring batch no: 0d6125216. Expiry date: not provided. Case (b)(4) is a spontaneous case report sent by a consumer which refers to a male age unknown. It was reported that on (b)(6) 2017, a male patient of an unknown age used durex pleasure ring for approximately 20 minutes. After using it he started feeling pain and discomfort from the lower abdomen to the penis, glans and perineum region. The pain was more intense in his testicles, anus and penis. Reporter also stated that different symptoms appeared due to the pain and discomfort explained before, such as; lack of penis sensitivity, flaccidity, irregular erection and difficulty to keep it as well ejaculation problems, decreased urine flow and bleeding during and post defecation. All of that was accompanied by depression as a consequence of all the symptoms. Treatment continued and tests were being conducted to dismiss other potential damage. Treatment had been reported but it was unclear which events were treated. This case has been deemed serious due to serious deterioration in state of health of patient. Follow up has been requested to obtain further information. The company's assessment is serious with a relatedness of possible and unanticipated. Case outcome: not recovered / not resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009722622-2018-00007 |
| MDR Report Key | 7759199 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-07 |
| Date Mfgr Received | 2018-07-10 |
| Date Added to Maude | 2018-08-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JOANNE MARTINEZ |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | HU8 7DS |
| Manufacturer G1 | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HULL,HU8 |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HULL, HU8 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUREX ANILLO DE PLACER |
| Generic Name | DUREX PLEASURE RING |
| Product Code | LKY |
| Date Received | 2018-08-07 |
| Lot Number | 0D6125216 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Address | DANSOM LANE HULL, HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-07 |