FDA Adverse Event
Other
Summary report: N
SILVERDRESSING
MDR report key: 1071756
·
Received July 8, 2008
Report
- Report Number
- 3029160-2008-00002
- Event Type
- Other
- Date Received
- July 8, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 27, 2008
- Manufacturer
- ACRYMED, INC.
- Product Code
- FRO
- PMA / PMN Number
- K061232
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
REFERENCE MFR REPORT # 3029160-2008-00001
Description of Event or Problem · 1
OUR CUSTOMER, I-FLOW CORPORATION, REPORTED THAT THEY FOUND WHAT THEY BELIEVE TO BE FAULTY SEALS ON THE FOIL POUCHES. THEY REPORTED THAT THIS WAS DISCOVERED DURING A PACKAGING VALIDATION. THEY EXPRESSED CONCERN REGARDING A POSSIBLE STERILITY COMPROMISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILVERDRESSING | SILVER DRESSING | FRO | ACRYMED, INC. | NA | H0705J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |