MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-01 for DYNJV0012J manufactured by Medline Industries.
[68668002]
It was reported during a c-section, fibers came of the sponge into the surgical site. The fibers came off sponges as they dabbed the surgical site, fibers were visible to the eye and easily identified. The surgeon removed fibers from the site by using forceps. The procedure was completed without further incident. The procedure was not delayed. No injury came to the patient. Sample was received and issue confirmed. In an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[68668003]
It was reported a fibers from the sponge fell into the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00003 |
| MDR Report Key | 6368769 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-01 |
| Date of Report | 2017-03-01 |
| Date Mfgr Received | 2017-02-09 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2017-03-01 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8477703962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | LAP SPONGE IN C-SECTION PACK |
| Product Code | OHM |
| Date Received | 2017-03-01 |
| Catalog Number | DYNJV0012J |
| Lot Number | 16UB5615 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-01 |