D
Patient 1
WHEN DOING ENEMA, A WHITE SLIDE CLIP/CLAMP SLIPPED OFF END OF CATHETER AND INTO PT'S RECTUM. PT PASSED THE ITEM HOURS LATER. NO INJURY OCCURRED.
MAUDE MDR 321775
- MDR report key
- 321775
- Report number
- MW1021395
- Event key
- 0
- Event type
- 3
- Date of event
- 2001-03-16
- Date received
- 2001-03-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 | MEDICAL DEVICES INTERNATIONAL | CLEANSING ENEMA SET | MEDICAL DEVICES INT'L | FCE | * | 50-750 | * | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2001-03-19 | 0 |