FDA Adverse Event
Malfunction
Summary report: N
MINICAP
MDR report key: 2250353
·
Received September 15, 2011
Report
- Report Number
- 1423500-2011-12286
- Event Type
- Malfunction
- Date Received
- September 15, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 22, 2011
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- KDI
- PMA / PMN Number
- K895631
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 1
(B)(4).THIS COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE FOR THE REPORT OF INADEQUATE IODINE WAS UNDETERMINED.
Description of Event or Problem · 1
A CONSUMER REPORTED A QUANTITY OF 12 MINICAPS IN WHICH THE SPONGE IN THE MINICAP WAS BROWN, BUT DRY. THE PACKAGE WAS NOT OPENED OR DAMAGED PRIOR TO USE. THE SAMPLE WAS DISCARDED AND LOT NUMBER WAS UNKNOWN. THE CONSUMER IS USING A NEW BOX OF MINICAPS WITH NO REPORTED PROBLEMS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 10 OF 12
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINICAP | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - CLEVELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | DIANEAL PD4 AMBUFLEX| HOMECHOICE |