MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-02 for DYNJ44989F manufactured by Medline Industries Inc.
[90859426]
It was reported that "the gauze came apart while in the patient. " it is unknown how the gauze was found or removed from the surgical site. Although a number of attempts were made to attempt to obtain additional information, the account did not provide any further details regarding this incident. The actual sample was returned for evaluation. The edges of the gauze that seemed to be attached to each other at one point were frayed and some of the threads were no longer woven together indicating a possibility that the gauze was cut, but a definitive root cause could not be determined with the sample provided. No injury or further intervention was reported. However, due to the reported incident and in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[90859427]
The facility reported that the gauze came apart today while in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00026 |
| MDR Report Key | 6995956 |
| Report Source | USER FACILITY |
| Date Received | 2017-11-02 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-10-06 |
| Date Mfgr Received | 2017-10-06 |
| Date Added to Maude | 2017-11-02 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DR |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Manufacturer G1 | MEDLINE INDUSTRIES INC |
| Manufacturer Street | THREE LAKES DR. |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | GAUZE IN MINOR PROCEDURE PACK |
| Product Code | FDE |
| Date Received | 2017-11-02 |
| Returned To Mfg | 2017-10-25 |
| Catalog Number | DYNJ44989F |
| Lot Number | 17RB6679 |
| 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 DR NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-02 |