MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-03 for DYNJ51730 manufactured by Medline Industries Inc..
[104431839]
It was reported that during a breast mastectomy procedure, a fiber came off of the lap sponge and was retrieved from the surgical site by the surgeon through an unknown method. There was no serious injury or follow-up care reported related to the event. There was no reported impact to the patient, the procedure, or a staff member. General anesthesia was used; however, there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. The sample is not available to be returned for evaluation however pictures of the incident were provided. The customer reported issue was confirmed. A root cause has not been determined. No additional information is available. Due to the reported incident and in an abundance of caution, this medwatch is being filed. No additional information was provided. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[104431840]
It was reported that a fiber came off of a lap sponge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00014 |
| MDR Report Key | 7393474 |
| Date Received | 2018-04-03 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-03-12 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2018-04-03 |
| 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 | BERMON WREN PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | DBD-PATEWOOD MAJOR BREAST |
| Product Code | FTN |
| Date Received | 2018-04-03 |
| Catalog Number | DYNJ51730 |
| Lot Number | 17VB8352 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-03 |