MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-03 for L.UNK manufactured by Nulatex Sdn Bhd.
| Report Number | 1216894-2019-00001 |
| MDR Report Key | 8955354 |
| Date Received | 2019-09-03 |
| Date of Report | 2019-06-30 |
| Date Facility Aware | 2019-06-30 |
| Date Added to Maude | 2019-09-03 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | L.UNK |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2019-09-03 |
| Lot Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NULATEX SDN BHD |
| Manufacturer Address | KLUANG JOHOR, 86000 MY 86000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-03 |