MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-02 for 2-0 ETHILON UNK manufactured by Ethicon, Inc..
[87875295]
Patient Sequence No: 1, Text Type: N, H10
[87875296]
During wound closure, the suture needle broke while passing the suture through the subcutaneous tissue. New needle was used to close the wound with no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6906736 |
| MDR Report Key | 6906736 |
| Date Received | 2017-10-02 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-07-07 |
| Report Date | 2017-09-08 |
| Date Reported to FDA | 2017-09-08 |
| Date Reported to Mfgr | 2017-09-08 |
| Date Added to Maude | 2017-10-02 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 2-0 ETHILON |
| Generic Name | SUTURE |
| Product Code | NOV |
| Date Received | 2017-10-02 |
| Model Number | UNK |
| Lot Number | UNK |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST P.O. BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-02 |