MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-06-15 for PISTON FOR 7-9 MM BLADES 0001741 manufactured by Xomed Surgical Products, Inc..
[155933]
Corneal transplant procedure using weck trephine, piston and cutting block resulted in leaking around the transplanted cornea. Add'l surgery performed 5/11/99 to seal leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-1999-00007 |
| MDR Report Key | 227781 |
| Report Source | 05,06 |
| Date Received | 1999-06-15 |
| Date of Report | 1999-05-12 |
| Date of Event | 1999-05-11 |
| Date Mfgr Received | 1999-05-12 |
| Date Added to Maude | 1999-06-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PISTON FOR 7-9 MM BLADES |
| Generic Name | CORNEAL PUNCH |
| Product Code | HNJ |
| Date Received | 1999-06-15 |
| Returned To Mfg | 1999-06-01 |
| Model Number | NA |
| Catalog Number | 0001741 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 220882 |
| Manufacturer | XOMED SURGICAL PRODUCTS, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US |
| Baseline Brand Name | PISTON FOR 7-9MM BLADES |
| Baseline Generic Name | CORNEAL PUNCH |
| Baseline Model No | NA |
| Baseline Catalog No | 0001741 |
| Baseline ID | NA |
| Baseline Device Family | CORNEAL PUNCH |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K791988 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Required No Informationntervention | 1999-06-15 |