MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-08 for DYNJ51754B manufactured by Medline Industries Inc..
[128325181]
It was reported that the x-ray detectable gauze frayed in the wound during the excision of a lesion to the patient's back. Per report, fraying of the x-ray detectable gauze was noted in the middle of the procedure and a tissue forceps was used to successfully retrieve the frayed fibers of the x-ray detectable gauze from the patient. The patient was reportedly under local anesthesia at the time of the incident. No impact to the patient, the procedure, or the total length of the procedure was reported. The patient is reportedly doing well at this time with no report of any complications related to the reported event. There was no serious injury or follow-up care reported. Due to the reported incident, this medwatch is being filed. The sample was returned for evaluation and the complaint is confirmed. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[128325182]
It was reported that fraying of the x-ray detectable gauze was noted in the middle of the procedure and a tissue forceps was used to successfully retrieve the frayed fibers of the x-ray detectable gauze from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00055 |
| MDR Report Key | 8051260 |
| Date Received | 2018-11-08 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2018-10-22 |
| Date Added to Maude | 2018-11-08 |
| 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 | 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 | XRAY DETECTABLE GAUZE FROM MINOR ACTION PACK |
| Product Code | FDE |
| Date Received | 2018-11-08 |
| Returned To Mfg | 2018-10-24 |
| Catalog Number | DYNJ51754B |
| Lot Number | 18FBB172 |
| 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 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-08 |