MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-08-27 for ULTRA-FIT PK SYSTEM 11840-775 manufactured by Network Medical.
[1459841]
The date of event is estimated. The doctor reported that during an ophthalmic procedure, extra anesthesia time was required due to defective trephine products. The procedure was delayed so that replacement products could be located. Potential safety issues could arise from additional time under general anesthesia.
Patient Sequence No: 1, Text Type: D, B5
[8519532]
The date of event is estimated. Three (3) other ultra-fit pk system products were also reported. The product info is as follows: model / catalog #: 11840-775; lot #: 081442; exp date: 09/30/2011. Model / catalog #: 11840-800; lot #: 081916; exp date: 11/30/2011. Model / catalog #: 11840-800; lot #: 081577; exp date: 10/31/2011. (b)(4). A 11840-775, ultra-fit pk system,. 775mm vacuum trephine. A 11840-800, ultra-fit pk system,. 800mm vacuum trephine.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2522801-2009-00021 |
| MDR Report Key | 1623510 |
| Report Source | 99 |
| Date Received | 2009-08-27 |
| Date of Report | 2009-08-18 |
| Date of Event | 2009-07-21 |
| Date Facility Aware | 2009-07-21 |
| Report Date | 2009-08-18 |
| Date Reported to FDA | 2009-08-18 |
| Date Reported to Mfgr | 2009-07-21 |
| Date Added to Maude | 2010-09-29 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA-FIT PK SYSTEM |
| Generic Name | CORONET VACUUM TREPHINE |
| Product Code | HRH |
| Date Received | 2009-08-27 |
| Returned To Mfg | 2009-07-31 |
| Model Number | 11840-775 |
| Catalog Number | 11840-775 |
| Lot Number | 081703 |
| ID Number | NA |
| Device Expiration Date | 2011-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NETWORK MEDICAL |
| Manufacturer Address | NORTH YORKSHIRE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-27 |