MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-04 for SKYN manufactured by Suretex Prophylactics (i), Ltd.
[63909888]
On 12/29/2016 - a review of the device history record indicates that compounding and manufacturing process were all within specified parameters. Inspection of (b)(4) pieces of retained samples were tested for lubricant quantity and results are within specification requirements of the product. (b)(4) pieces of retained samples have been sent to outside microbiological lab for testing and another (b)(4) retain samples sent to external laboratory for protein test (protein's associated with latex allergen). This report will be updated upon completion of the those evaluations.
Patient Sequence No: 1, Text Type: N, H10
[63909889]
(b)(6) 2016 user indicated that they were having an allergic reaction from the use of skyn large polyisoprene condom. The user wished to know the ingredients used in the production of the condom, so that she could discuss with her physician as to whether an ingredient(s) contributed to the reaction.
Patient Sequence No: 1, Text Type: D, B5
[71878409]
On 12/29/2016 - a review of the device history record indicates that compounding and manufacturing process were all within specified parameters. Inspection of 13 pieces of retained samples were tested for lubricant quantity and results are within specification requirements of the product. Ten (10) pieces of retained samples have been sent to outside microbiological lab for testing and another 10 retain samples sent to external laboratory for protein test (protein's associated with latex allergen). This report will be updated upon completion of the those evaluations. On 03/03/2017 - retain evaluations for microbial testing indicated retain samples passed parameters. Aqueous extractable protein evaluation showed results within acceptable limit. No further action to be taken.
Patient Sequence No: 1, Text Type: N, H10
[71878410]
On 12/23/2016 user indicated that they were having an allergic reaction from the use of skyn large polyisoprene condom. The user wished to know the ingredients used in the production of the condom so that she could discuss with her physician as to whether an ingredient(s) contributed to the reaction
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2017-00001 |
| MDR Report Key | 6223274 |
| Date Received | 2017-01-04 |
| Date of Report | 2017-03-30 |
| Date of Event | 2016-12-13 |
| Date Facility Aware | 2016-12-13 |
| Report Date | 2017-01-04 |
| Date Reported to FDA | 2017-01-04 |
| Date Reported to Mfgr | 2017-01-04 |
| Date Added to Maude | 2017-01-04 |
| 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 |
| Generic Name | SKYN LARGE POLYISOPRENE LUBRICATED CONDOM |
| Product Code | MOL |
| Date Received | 2017-01-04 |
| Lot Number | 1606P10722 |
| 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 ESTATE JIGANI II PHASE, ANEKAL TALUK BANGALORE KARNATAKA, BANGALORE 562106 IN 562106 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-04 |