MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for DUREX REAL FEEL manufactured by Reckitt Benckiser Healthcare Int. Limited.
[119151880]
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 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 "no method of contraception can provide 100% protection against pregnancy or the transmission of hiv and stis. " the company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[119151881]
Patient lost a baby after 8th weeks of pregnancy [abortion spontaneous]. Condom broke during intercourse and patient got pregnant [pregnancy with contraceptive device]. Condom broke during intercourse [device breakage]. Case description: initial report, received date: (b)(6) 2018 received from consumer relations, country: (b)(6), reference no: (b)(4). Medical device: durex real feel condom. Batch no: 1000232445. Case reference number (b)(6) 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 real feel condom for an unknown indication. Patient stated that condom broke during intercourse and she got pregnant. Follow up has been requested to obtain further information. The company's assessment is non serious with a relatedness of possible and unanticipated. Case outcome: unknown. Report no 2, received date: (b)(6) 2018 received from consumer relations, country: (b)(6), reference no: (b)(4). Information added / updated: the case has been upgraded from non-serious to serious. Adverse event: "patient lost a baby after 8th weeks of pregnancy" was added. Company diagnosis: updated from "condom failure pregnancy" to "spontaneous abortion". Trimester of exposure: "first" was added. Patient stated that she lost a baby after eight weeks of pregnancy and she had to stay in the hospital, to check her body. At the time of reporting, action taken with the suspect product and case outcome were unknown. The patient was admitted to hospital, admittance date, discharge date and days in hospital were unknown. The case was deemed serious as it was classed as medically significant due to abortion spontaneous and hospitalization. Follow up has been requested to obtain further information. The company's assessment is serious with a relatedness of conditional and unanticipated. Case outcome: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2018-00010 |
| MDR Report Key | 7844657 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-08-31 |
| Date Mfgr Received | 2018-08-13 |
| Date Added to Maude | 2018-09-04 |
| 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 | 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, HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU8 7DS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DUREX REAL FEEL |
| Generic Name | DUREX REAL FEEL CONDOM |
| Product Code | MOL |
| Date Received | 2018-09-04 |
| Lot Number | 1000232445 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Other | 2018-09-04 |