N
Patient 1
ON 02/16/2017 A FIRST REVIEW OF RELEASE RECORD INDICATES THAT THE DEVICE MET ALL SPECIFICATIONS FOR RELEASE. FURTHER EVALUATION ON GOING.
MAUDE MDR 6336950
- MDR report key
- 6336950
- Report number
- 1019632-2017-00004
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-02-10
- Date received
- 2017-02-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- D
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LIFESTYLES | NATURAL RUBBER LATEX CONDOM | SURETEX PROPHYLACTICS (I), LTD | HIS | 1601181922 | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-16 | 0 | 1. R |
Event Narratives#
D
Patient 1
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.
N
Patient 1
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.
D
Patient 1
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.
N
Patient 1
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.
D
Patient 1
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.