FDA Adverse Event
Other
Summary report: N
KNIFE
MDR report key: 2116660
·
Received May 27, 2011
Report
- Report Number
- 2523835-2011-00060
- Event Type
- Other
- Date Received
- May 27, 2011
- Report Date
- April 27, 2011
- Manufacturer
- ALCON PRECISION DEVICE-SINKING SPRING
- Product Code
- HNN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER DID NOT RETURN PRODUCT SAMPLE FOR EVAL. THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. NO ROOT CAUSE CAN BE DETERMINED. (B)(4).
Description of Event or Problem · 1
A SURGEON OBSERVED THAT THE KNIVES ARE NOT SHARP. ADD'L INFO PROVIDED INDICATED A SUTURE IS OFTEN REQUIRED TO CLOSE THE INCISION. THE OUTCOME OF THE PTS INVOLVED ARE UNK. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KNIFE | MANUAL OPHTHALMIC SURGICAL INSTRUMENT | HNN | ALCON PRECISION DEVICE-SINKING SPRING | 8065992245 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |