MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-11 for SKYN SYNTHETIC POLYISOPRENE CONDOM 114668 manufactured by Suretex Prophylactics (i), Ltd..
[108050766]
On (b)(4) 2018 device history record evaluation conducted. Batch record indicates no deviations from established acceptance criteria. Retain samples subject to microbiological testing, results indicate total yeast and mold below cfu requirement and absence of bacteria. No other deviations noted in batch record and no root cause can be established. No further action to be taken.
Patient Sequence No: 1, Text Type: N, H10
[108050767]
On (b)(6) 2018 (b)(6) customer indicates that after use of the product, the penis developed hives. Medical advice was sought and the consumer was advised to cease use of the product. No medication was prescribed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013388459-2018-00006 |
| MDR Report Key | 7507729 |
| 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 | 2018-04-27 |
| 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 | SKYN SYNTHETIC POLYISOPRENE CONDOM |
| Generic Name | POLYISOPRENE CONDOM |
| Product Code | MOL |
| Date Received | 2018-05-11 |
| Catalog Number | 114668 |
| Lot Number | 1711971822 |
| 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 |