D
Patient 1
WOUND DRAIN BROKE AT THE FLAT WHITE PART, APPROXIMATELY ONE INCH INSIDE THE PATIENT'S ABDOMEN UPON REMOVAL BY NURSE PER THE DOCTOR'S ORDERS. PATIENT WAS RETURNED TO SURGERY TO HAVE THE INDWELLING DRAIN PORTION REMOVED.
MAUDE MDR 451334
- MDR report key
- 451334
- Report number
- 1018233-2003-00006
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-01-31
- Date received
- 2003-03-28
- 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 FLAT SILICONE DRAIN | WOUND DRAIN | C.R. BARD, INC. | GCY | NA | 0070370 | UNK | K782026 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2003-03-28 | 0 | 1. R |