MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-02-27 for DUREX SENSITIVO CONTACTO TOTAL(SPAIN), DUREX INVISIBLE CONDOM (USA) manufactured by Reckitt Benckiser Healthcare Int. Limited.
| Report Number | 3008559248-2020-00010 |
| MDR Report Key | 9765057 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-06 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2019-07-01 |
| Date Added to Maude | 2020-02-27 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOANNE MARTINEZ |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, UNITED KINGDOM |
| Manufacturer Country | US |
| Manufacturer Phone | 4042478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUREX SENSITIVO CONTACTO TOTAL(SPAIN), DUREX INVISIBLE CONDOM (USA) |
| Generic Name | DUREX CONDOM |
| Product Code | HIS |
| Date Received | 2020-02-27 |
| Lot Number | 1000826152 |
| 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, UNITED KINGDOM HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-27 |