MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-16 for LIFESTYLES manufactured by Suretex Prophylactics (i), Ltd.
[67646922]
On 02/16/2017 a first review of release record indicates that the device met all specifications for release. Further evaluation on going.
Patient Sequence No: 1, Text Type: N, H10
[67646923]
On (b)(6) 2017 user indicated that they received product from a public health service administered by the state of (b)(6). After using a lifestyles ultra lubricated latex condom, the user experienced contact dermatitis reaction. He later went to a dermatologist who provided a topical ointment treatment. User has communicated that they went to a allergist, conducted a patch test and showed allergy to me-isthiazolinone and parabens but not latex allergy; a copy of a report has not been provided to ansell.
Patient Sequence No: 1, Text Type: D, B5
[67886092]
On (b)(6) 2017 a first review of release record indicates that the device met all specifications for release. Further evaluation on going (b)(6) 2017 13 pcs of same lot product were tested for microbial testing. Results are all within required specifications. No assignable cause can be found from a review of the dhr and inspection of retained samples. No further investigation or correction action identified.
Patient Sequence No: 1, Text Type: N, H10
[67886093]
On (b)(6) 2017 user indicated that they received product form a public health service administered by the state of (b)(4). After using a lifestyles ultra lubricated latex condom, the user experienced contact dermatitis reaction. He later went to a dermatologist who provided a topical ointment treatment. User has communicated that they went to a allergist, conducted a patch test and showed allergy to me-isthiazolinone and parabens but not latex allergy; a copy of a report has not been provided to ansell.
Patient Sequence No: 1, Text Type: D, B5
[71372628]
On 02/16/2017 a first review of release record indicates that the device met all specifications for release. Further evaluation on going. On 2/21/2017 13 pcs of same lot product were tested for microbial testing. Results are all within required specifications. No assignable cause can be found from a review of the dhr and inspection of retained samples. No further investigation or correction action identified on 03/30/2017 retain samples went through microbial testing; results were within specification. Customer samples were received and sent for microbial testing; results were within specification. No other action to be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
[71372629]
On 02/16/2017 user indicated that they received product form a public health service administered by the state of (b)(4). After using a lifestyles ultra lubricated latex condom, the user experienced contact dermatitis reaction. He later went to a dermatologist who provided a topical ointment treatment. User has communicated that they went to a allergist, conducted a patch test and showed allergy to me-isothiazolinone and parabens but not latex allergy; a copy of a report has not been provided to ansell.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2017-00004 |
| MDR Report Key | 6336950 |
| Date Received | 2017-02-16 |
| Date of Report | 2017-03-30 |
| Date of Event | 2017-02-10 |
| Date Facility Aware | 2017-02-10 |
| Report Date | 2017-02-16 |
| Date Reported to FDA | 2017-02-16 |
| Date Reported to Mfgr | 2017-02-16 |
| Date Added to Maude | 2017-02-16 |
| 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 |
| Generic Name | NATURAL RUBBER LATEX CONDOM |
| Product Code | HIS |
| Date Received | 2017-02-16 |
| Returned To Mfg | 2017-02-21 |
| Lot Number | 1601181922 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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. Required No Informationntervention | 2017-02-16 |