FDA Adverse Event
Other
Summary report: N
SENTINEL SEAL
MDR report key: 123177
·
Received September 29, 1997
Report
- Report Number
- 9611018-1997-00007
- Event Type
- Other
- Date Received
- September 29, 1997
- Report Date
- July 8, 1997
- Manufacturer
- SHERWOOD MEDICAL INDUSTRIES
- Product Code
- KDQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
ONE SAMPLE WAS RETURNED AND EVALUATED. THE STEM ADAPTER WAS BROKEN OFF. THIS ADAPTER USED THE K RESIN MATERIAL VALIDATED IN JULY 1996. DUE TO CUSTOMER COMPLAINTS, TULLAMORE HAS RETURNED TO USING THE ORIGINAL POLYCARBONATE MATERIAL WHICH SHOULD ELIMINATE THIS TYPE OF COMPLAINT.
Description of Event or Problem · 1
CUSTOMER REPORTS, THE CONNECTION TIP AT THE SUCTION SOURCE BROKE. A SECOND UNIT WAS USED AND PRESENTED THE SAME PROBLEM. SUCTION WAS IMPOSSIBLE. THE PT'S STATE OF HEALTH WAS REPORTEDLY AGGRAVATED, "HAVING AN OPERATION ON HEMITHORAX OPPOSITE AT THE ONE STRUCK DOWN BY A PNEUMOTHORAX." REPORTEDLY, THE PNEUMOTHORAX WAS NOT CAUSED BY THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENTINEL SEAL | CHEST DRAINAGE UNIT | KDQ | SHERWOOD MEDICAL INDUSTRIES | NA | SEE H-10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |