MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-12-07 for LIFESTYLES ULTRA SENSITIVE 1712 manufactured by Suretex Ltd..
[16746541]
Customer informed (b)(4) healthcare products llc that after using the lifestyles ultra sensitive condom he experienced an allergic reaction. He advised that he has been to the doctor and been treated by medication. Also, he is scheduled to see a dermatologist on (b)(6), 2012.
Patient Sequence No: 1, Text Type: D, B5
[16950693]
(b)(4) healthcare products llc is submitting this report on behalf of suretex(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1019632-2012-00013 |
| MDR Report Key | 2897440 |
| Report Source | 04 |
| Date Received | 2012-12-07 |
| Date of Report | 2012-12-07 |
| Date Facility Aware | 2012-12-06 |
| Report Date | 2012-12-07 |
| Date Reported to FDA | 2012-12-07 |
| Date Reported to Mfgr | 2012-12-07 |
| Date Mfgr Received | 2012-12-06 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2013-01-07 |
| 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 |
| Manufacturer Contact | TAMMY MCGRIFF |
| Manufacturer Street | 1635 INDUSTRIAL RD. |
| Manufacturer City | DOTHAN AL 36303 |
| Manufacturer Country | US |
| Manufacturer Postal | 36303 |
| Manufacturer Phone | 3346152566 |
| Manufacturer Street | PLOT NO. 74 TO 91, KIABD IND., ESTATE JIGANI-2ND PHASE, ANEKAI |
| Manufacturer City | BANGALORE, KARNATAKE 560105 |
| Manufacturer Country | IN |
| Manufacturer Postal Code | 560 105 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESTYLES ULTRA SENSITIVE |
| Generic Name | LUBRICATED LATEX CONDOM |
| Product Code | LTZ |
| Date Received | 2012-12-07 |
| Returned To Mfg | 2012-12-07 |
| Catalog Number | 1712 |
| Lot Number | 1111020822 |
| Device Expiration Date | 2016-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURETEX LTD. |
| Manufacturer Address | BANGALORE IN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-07 |