FDA Adverse Event
Malfunction
Summary report: N
30359 4050 BAG-IT - CLEAR BACK
MDR report key: 1517974
·
Received October 22, 2009
Report
- Report Number
- 1282497-2009-00040
- Event Type
- Malfunction
- Date Received
- October 22, 2009
- Date of Event
- July 28, 2008
- Report Date
- August 20, 2008
- Manufacturer
- COM-PAC INTERNATIONAL
- Product Code
- LWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON 08/20/2008 THAT A CUSTOMER HAD AN ISSUE WITH A SPONGE COUNTER BAG. THE CUSTOMER REPORTS THAT A LAPARATOMY (ABDOMINAL) PROCEDURE WAS PERFORMED ON A (B) (6) MALE PT IN GOOD HEALTH. AFTER 1-2 DAYS, PT COMPLAINED OF ABDOMINAL PAIN. AN X-RAY REVEALED THE SPONGE AND THE PT REQUIRED ADD'L SURGERY TO REMOVE THE SPONGE WHICH ALSO INCREASED HIS LENGTH OF STAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 30359 4050 BAG-IT - CLEAR BACK | SPONGE COUNTER BAG | LWH | COM-PAC INTERNATIONAL | 31144119 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Hospitalization |