MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-05 for DYNJ40199D manufactured by Medline Industries Inc..
[110591677]
It was reported that the blue-radiopaque stitching from an unknown component in the neuro pack came loose into the surgical wound. Upon follow-up, no additional information is available related to this reported event as the reporter stated that the reporting facility did not log a formal event. Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details. There was no serious injury reported related to this event. Due to the reported incident and in an abundance of caution, this medwatch is being filed. The sample is not available to be returned for evaluation. A root cause cannot be determined at this time. No additional information is available. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[110591678]
It was reported that the blue-radiopaque stitching from an unknown component in the neuro pack came loose into the surgical wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00033 |
| MDR Report Key | 7569492 |
| Date Received | 2018-06-05 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-05-23 |
| Date Added to Maude | 2018-06-05 |
| 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 | NEURO PACK |
| Product Code | OJG |
| Date Received | 2018-06-05 |
| Catalog Number | DYNJ40199D |
| Lot Number | 18OB9600 |
| 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. Other | 2018-06-05 |