D
Patient 1
PHYSICIAN REPORTED PT DEVELOPED STAPH INFECTION FOLLOWING USE OF LAMINARIA (5DAYS). DR COULD NOT CONFIRM THAT DEVICE CAUSED INFECTION. PHYSICIAN SENT MEDWATCH REPORT TO MFR ON FRIDAY 14 JULY AFTER NORMAL HOURS.
MAUDE MDR 293262
- MDR report key
- 293262
- Report number
- 1450908-2000-00001
- Event key
- 0
- Event type
- 3
- Date received
- 2000-08-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- * * *
- Phone
- **
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LAMINARIA | UTERINE DIALATOR | MEDGYN PRODUCTS INC. | HDY | 8MM | 108 | 102691 | Y | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-08-10 | 0 | 1. H; 2. R |