MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-21 for EDHICON MONOCRYL 3-0 manufactured by Ethicon.
[15916257]
Monocryl 3-0 was being used by physician to stitch peritoneal tissue. When she put the needle into the tissue and removed the needle holder to grab the other end of the needle, the suture broke off right where it connected to the needle. The md was not certain whether it was still in the pt or if it had flipped off the field somewhere. The pt had to wait in the operating room until an x-ray was done to determine if the needle was in the abdomen. The needle was identified in the abdomen, but unsure of the depth, so another x-ray was taken from the side to determine where the needle was located. The md tried to use a magnet to find the needle to no avail. The physician had to manually feel the subcutaneous tissue to find the needle, luckily she did not get stuck. The lot number is eam348.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4833886 |
| MDR Report Key | 4833886 |
| Date Received | 2015-05-21 |
| Date of Report | 2015-05-15 |
| Date of Event | 2015-05-14 |
| Date Facility Aware | 2015-05-14 |
| Report Date | 2015-05-15 |
| Date Added to Maude | 2015-06-11 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDHICON MONOCRYL 3-0 |
| Generic Name | NEEDLE |
| Product Code | MOF |
| Date Received | 2015-05-21 |
| Lot Number | EAM348 |
| Device Expiration Date | 2017-01-01 |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-21 |