N
Patient 1
AT THIS TIME, INSUFFICIENT INFORMATION HAS BEEN PROVIDED BY THE INITIAL REPORTER TO IDENTIFY WHICH OF THE TWO MANUFACTURING FACILITIES THE DEVICE COULD HAVE COME FROM. (B)(4).
MAUDE MDR 5490245
- MDR report key
- 5490245
- Report number
- 1019632-2016-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-02-17
- Date received
- 2016-03-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 305
- 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 | HIS | NOT PROVIDED | NOT PROVIDED | NOT PROVIDED | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-03-09 | 0 | 1. H |
Event Narratives#
D
Patient 1
CONTACT ADVISED THAT HE AND GIRLFRIEND USED A LIFESTYLE CONDOM (NO SPECIFIC PRODUCT NAME, LOT CODE, OR PRODUCT IDENTIFIER INFORMATION PROVIDED). AFTERWARDS, THERE WERE COMPLICATIONS THAT RESULTING IN SPENDING 8 HOURS IN A EMERGENCY ROOM AT A HOSPITAL. NO OTHER INFORMATION PROVIDED.