MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for SKYN POLYISOPRENE MALE CONDOMS 828714 manufactured by Suretex Prophylactics (i), Ltd..
[90935775]
(b)(6) 2017 sample and further information concerning the event received (b)(6) (initial contact was (b)(6) but in complete information concerning the nature of event not provided till later).
Patient Sequence No: 1, Text Type: N, H10
[90935776]
(b)(6) 2017 customer indicated that wife complained of condom odor and abdominal pain after using the product. After inquiries for details of the pain and whether doctor intervention was required, company was advised on (b)(6) 2017 that an antibiotic was prescribed and that they had abdominal pain when using a new condom.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2017-00014 |
| MDR Report Key | 6997679 |
| Date Received | 2017-11-02 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-09-20 |
| Date Facility Aware | 2017-09-20 |
| Report Date | 2017-11-02 |
| Date Reported to FDA | 2017-11-02 |
| Date Reported to Mfgr | 2017-11-02 |
| Date Added to Maude | 2017-11-02 |
| 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 POLYISOPRENE MALE CONDOMS |
| Generic Name | SKYN POLYISOPRENE MALE CONDOMS |
| Product Code | MOL |
| Date Received | 2017-11-02 |
| Returned To Mfg | 2017-10-31 |
| Catalog Number | 828714 |
| Lot Number | 1704P20722 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-11-02 |