MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-29 for SILICONE DRAIN 19F, END manufactured by Medline Industries, Inc..
[1472178]
Patient had undergone ventral hernia repair on (b)(6)2010 at (b)(6) medical center. One silicone 19f drain was purposefully left in place. The patient was transferred to a long term acute care facility -promise suburban- with the drain intact. On (b)(6)2010, at the long term facility, the drain was removed. At the time of removal a part of the drain, approximately 15. 2 cm, was unintentionally retained. On (b)(6)2010, the patient presented to (b)(6) emergency department with 3 day history of abdominal pain. She was admitted and the retained drain piece -identified on ct scan- was surgically removed. Upon inspection, the piece appeared to have one end that was jagged and uneven, as if it had been torn apart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017653 |
| MDR Report Key | 1852957 |
| Date Received | 2010-09-29 |
| Date of Report | 2010-09-29 |
| Date of Event | 2010-09-27 |
| Date Added to Maude | 2010-10-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE DRAIN |
| Generic Name | SILICONE DRAIN |
| Product Code | GBW |
| Date Received | 2010-09-29 |
| Model Number | 19F, END |
| Lot Number | P0816311 |
| ID Number | DYNJWE1325A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060448 US 60060 4488 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2010-09-29 |