MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-14 for DYNJ47225B manufactured by Medline Industries Inc..
[111681877]
It was reported that the white thread of the gauze unraveled inside the surgical wound during an umbilical hernia repair. Per report, the surgeon used his hand to manually pick-up and to successfully retrieve the white thread from the surgical wound. There was no reported impact to the patient, the staff, or the procedure being performed. 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. Due to the reported incident and in an abundance of caution, this is an mdr reportable event. The sample was returned for evaluation and the complaint was confirmed. A root cause could not be identified at this time. No additional information is available. If additional information becomes available, this report will be reopened and reevaluated.
Patient Sequence No: 1, Text Type: N, H10
[111681878]
It was reported that the white thread of the gauze unraveled inside the surgical wound during an umbilical hernia repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00035 |
| MDR Report Key | 7600985 |
| Date Received | 2018-06-14 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-05-11 |
| Date Mfgr Received | 2018-05-23 |
| Date Added to Maude | 2018-06-14 |
| 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 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 | MINOR PACK |
| Product Code | FDE |
| Date Received | 2018-06-14 |
| Returned To Mfg | 2018-05-29 |
| Catalog Number | DYNJ47225B |
| Lot Number | UNK |
| Operator | PHYSICIAN |
| 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 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-14 |