MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-21 for ETHICON SURGICAL STEEL 316L MONOFILAMENT M654 manufactured by Ethicon, Inc..
[121640904]
The pt was admitted for pericardiectomy for persistent pericarditis. At the time of sternal closure, the tip of the sternal wire needle was noted to have broken off; radiological imaging confirmed the presence of the fragment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080058 |
| MDR Report Key | 7901822 |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-09-12 |
| Date Added to Maude | 2018-09-24 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | ETHICON SURGICAL STEEL 316L MONOFILAMENT |
| Generic Name | STERNAL SUTURE, NONABSORBABLE STEEL |
| Product Code | GAO |
| Date Received | 2018-09-21 |
| Model Number | M654 |
| Lot Number | HME956 |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | SOMERVILLE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-21 |