MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-08 for DYNJ58845 manufactured by Medline Industries Inc..
[123521269]
It was reported that in the middle of a breast lumpectomy, gauze fiber was found to have linted into the surgical site. The surgeon was required to remove the linted gauze fiber with forceps and the surgical site was irrigated. The patient was under general anesthesia at the time of the incident. The procedure did not last longer than expected and the patient did not require additional anesthesia. The procedure was completed without further reported incident. No impact to the patient or the patient's stability reported. No serious injury or follow-up care reported. A sample of gauze fibers only were returned to the manufacturer. Neither the gauze nor the surgical pack were returned to the manufacturer for evaluation. A root cause could not be determined. Due to the need for medical intervention to remove the linted gauze fiber from the surgical site, this medwatch is being filed. If additional information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[123521270]
It was reported that in the middle of a breast lumpectomy, gauze fiber was found to have linted into the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00051 |
| MDR Report Key | 7942940 |
| Date Received | 2018-10-08 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2018-09-13 |
| Date Added to Maude | 2018-10-08 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | GAUZE IN DBD-MINOR PK |
| Product Code | FDE |
| Date Received | 2018-10-08 |
| Returned To Mfg | 2018-09-17 |
| Catalog Number | DYNJ58845 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-08 |