D
Patient 1
STRINGS DETACHED AT TIME OF REMOVAL AND THEN LAMINARIA BROKE DUE TO SOFTENING OF LAMINARIA.
MAUDE MDR 11288
- MDR report key
- 11288
- Report number
- MW4000112
- Event key
- 0
- Event type
- 3
- Date received
- 1994-01-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 109
- Health professional
- 3
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LAMINARIA EXTRA THIN | MEDGYN PRODUCTS, INC. | HDY | 062393 | N | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1994-01-31 | 0 |