MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 1996-12-04 for POLYESTER SUTURE 2830-23 manufactured by Cyanimid Canada, Inc..
[35826]
During a procedure for strabismus, the tip of the catheter needle bent easily as soon as the needle came in contact with the sclera. The doctor immediately removed the needle from the sclera at this point, and noted a tiny barb near the bending area. Subsequently, he examined the eye with an ophthalmoscope, and found no perforation in the sclera. Post-operatively, the pt has been doing well. No evidence of scleral perforation one month post-op.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627446-1996-00010 |
| MDR Report Key | 53877 |
| Report Source | 01,06 |
| Date Received | 1996-12-04 |
| Date of Report | 1996-11-05 |
| Date of Event | 1996-10-24 |
| Date Facility Aware | 1996-10-24 |
| Report Date | 1996-11-05 |
| Date Reported to Mfgr | 1996-11-05 |
| Date Mfgr Received | 1996-11-05 |
| Device Manufacturer Date | 1994-11-01 |
| Date Added to Maude | 1996-12-10 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYESTER SUTURE |
| Generic Name | SURGICAL SUTURE |
| Product Code | HMN |
| Date Received | 1996-12-04 |
| Model Number | NA |
| Catalog Number | 2830-23 |
| Lot Number | 4K0744 |
| ID Number | NA |
| Device Expiration Date | 1999-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 24 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 54464 |
| Manufacturer | CYANIMID CANADA, INC. |
| Manufacturer Address | 19400 TRANS CANADA HWY BAIE D'URFE, QUEBEC CA H9X 3N7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-04 |