MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for MONOCRYL 4-0 ETHICON SUTURE NEEDLE manufactured by Ethicon, Inc. / Johnson & Johnson.
[185220964]
Pt arrived to er with complaints of periumbilical pain. Ct scan performed and identified curvilinear metallic foreign body just inferior to the umbilicus concerning for retained needle. Exploratory laparotomy for removal of foreign object performed and per operative report, metallic foreign body resemble a broken needle. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093932 |
| MDR Report Key | 9883100 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-22 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | MONOCRYL 4-0 ETHICON SUTURE NEEDLE |
| Generic Name | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID |
| Product Code | GAM |
| Date Received | 2020-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. / JOHNSON & JOHNSON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-25 |