D
Patient 1
THE DRAIN CAME APART WHEN DR WAS REMOVING IT. DR HAD TO QUICKLY GRAB THE END THAT WAS STILL IN THE PT TO KEEP IT FROM GOING BACK INTO THE WOUND. DRAIN WAS THEN REMOVED WITHOUT ANY FURTHER COMPLICATIONS BEING REPORTED.
MAUDE MDR 307327
- MDR report key
- 307327
- Report number
- 1018233-2000-00032
- Event key
- 0
- Event type
- 3
- Date received
- 2000-11-28
- 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#
- Contact
- VIVIAN STEPHENS, MGR
- Address
- 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD HUBLESS FLAT SILICONE DRAIN | HUBLESS FLAT SILICONE DRAIN | C.R. BARD, INC. | GCY | NA | 0070370 | 76GK2054 | K782026 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-11-28 | 0 | 1. O |