MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-11 for LIFESTYLES NATURAL RUBBER LATEX CONDOMS UNKNOWN manufactured by .
[89157600]
On 10/11/2017 - no device identifier information provided from user. Awaiting input in order to continue investigation.
Patient Sequence No: 1, Text Type: N, H10
[89157601]
On 10/11/2017 customer indicated that there was a foreign object in the condom which caused a cut to the penis. No doctor intervention indicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2017-00013 |
| MDR Report Key | 6940382 |
| Date Received | 2017-10-11 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-09-27 |
| Date Facility Aware | 2017-09-27 |
| Report Date | 2017-10-11 |
| Date Reported to FDA | 2017-10-11 |
| Date Added to Maude | 2017-10-11 |
| 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 | LIFESTYLES NATURAL RUBBER LATEX CONDOMS |
| Generic Name | NATURAL RUBBER LATEX CONDOM |
| Product Code | HIS |
| Date Received | 2017-10-11 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-11 |