MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-06-05 for DUREX manufactured by Reckitt Benckiser Healthcare Int Limited.
| Report Number | 3003071219-2019-00006 |
| MDR Report Key | 8671614 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-06-05 |
| Date of Report | 2019-05-17 |
| Date Mfgr Received | 2019-05-17 |
| Date Added to Maude | 2019-06-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOANNE MARTINEZ |
| Manufacturer Street | 399 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 070540225 |
| Manufacturer Country | US |
| Manufacturer Postal | 070540225 |
| Manufacturer Phone | 9734042478 |
| 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 | 3 |
| Brand Name | DUREX |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2019-06-05 |
| 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, HU87DS UK HU87DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2019-06-05 |