MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-04-25 for DUREX REAL FEEL KONDOMI manufactured by Reckitt Benckiser Healthcare Int. Limited.
[106572447]
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 reporter 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 product labelling also states that " no method of contraception can give you 100% protection against pregnancy". The company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[106572448]
Spontaneous miscarriage [abortion spontaneous]. Patient had abundant bleeding [haemorrhage]. Patient got pregnant [pregnancy with contraceptive device]. Case description: initial report, received date: 30-mar-2018. Received from consumer relations, country: (b)(6), (b)(4). Suspect product: durex real condoms. Batch no: b21a201810. Expiry date: 01-oct-2018. (b)(4) is a spontaneous case report sent by a consumer which refers to a female age unknown. It was reported by the patient's husband that on an unknown date, his wife of an unknown age used the durex real condoms. Reporter stated that his wife got pregnant. She had abundant bleeding and they went directly to the hospital. Due to ovarian cysts it was even more complicated, doctors performed an operation, spontaneous miscarriage occurred. His wife still drinks antibiotics with regular monitoring of temperature and overall condition. Treatment had been reported but it was unclear which events were treated. The company's assessment is serious with a relatedness of possible and unanticipated. Case outcome: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2018-00004 |
| MDR Report Key | 7463240 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-04-25 |
| Date of Report | 2018-03-30 |
| Date Mfgr Received | 2018-03-30 |
| Date Added to Maude | 2018-04-25 |
| 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 LAN |
| Manufacturer City | HULL, HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | HU8 7DS |
| Manufacturer G1 | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Street | RECKITT BENCKISER HEALTHCARE I |
| 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 | 3 |
| Brand Name | DUREX REAL FEEL KONDOMI |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2018-04-25 |
| Lot Number | B21A201810 |
| Device Expiration Date | 2018-10-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-04-25 |