MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-11 for LIFESTYLES ULTRA SENSITIVE CONDOM 825446 manufactured by Suretex Prophylactics (i), Ltd..
[108050968]
On (b)(6) 2018 device history record evaluation conducted. Batch record indicates no deviations from established acceptance criteria. Dimension specification were within acceptance criteria (length over 180 mm and nominal width of 53 mm). A review of lot retains for dimension similarly were within specification. No other similar complaints received on this lot. Possible cause was incomplete rolling down of the condom by consumer which could cause constriction but no definite root cause could be established. No further actions taken.
Patient Sequence No: 1, Text Type: N, H10
[108050969]
On (b)(6) 2018 (b)(6) customer indicates that they visited physician after complaining the condom was too tight on the penis and believes that it caused penile varicose dorsal vein thromphlebitis. Doctor performed an ultrasound on the penis. Patient indicates that extra length of condom (towards closed end) caused the constriction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013388459-2018-00005 |
| MDR Report Key | 7507732 |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-04-04 |
| Date Facility Aware | 2018-04-10 |
| Report Date | 2018-05-11 |
| Date Reported to FDA | 2018-05-11 |
| Date Reported to Mfgr | 2018-04-10 |
| Date Added to Maude | 2018-05-11 |
| 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 ULTRA SENSITIVE CONDOM |
| Generic Name | NATURAL RUBBER LATEX CONDOM |
| Product Code | HIS |
| Date Received | 2018-05-11 |
| Catalog Number | 825446 |
| Lot Number | 171004062 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURETEX PROPHYLACTICS (I), LTD. |
| Manufacturer Address | 74-91 KIADB INDUSTRIAL ESTATE JIGANI II PHASE,ANEKAL TALUK BANGALORE KARNATAKA, IN-KA 560 105 IN 560 105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-11 |