FDA Adverse Event
Injury
Summary report: N
ARROW
MDR report key: 17391252
·
Received July 25, 2023
Report
- Report Number
- 3015537318-2023-00026
- Event Type
- Injury
- Date Received
- July 25, 2023
- Date of Event
- January 1, 1999
- Report Date
- July 25, 2023
- Manufacturer
- CODMAN & SHURTLEFF
- Product Code
- LKK
- PMA / PMN Number
- P890055
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
INTERA ONCOLOGY ACQUIRED PMA P890055 FROM CODMAN & SHURTLEFF/CERENOVOUS IN 2020. COMPLAINT RECORDS TRANSFERRED FROM THE PREVIOUS PMA HOLDER WERE REVIEWED AND A COMPLAINT RECORD FOR THIS SERIAL NUMBER WAS NOT LOCATED. BLANK INFORMATION IN THE MDR FORM REPRESENTS UNKNOWN INFORMATION. IF FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
DEVICE TRACKING CARD WAS RETURNED ON (B)(6), 2023 TRACKING MAILING STATING "PUMP WAS A DISASTER INTESTINES GREW AROUND IT + OPERATION TO REMOVE LASTED 7 HRS." ALSO STATED "DECEASED ON (B)(6), 1999" IMPLANT DATE FROM THE DEVICE TRACKING DATABASE WAS ON (B)(6), 1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2335621 | ARROW | IMPLANTABLE DRUG DELIVERY PUMP | LKK | CODMAN & SHURTLEFF | 3000-H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |