MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-15 for DYNJ0843099D manufactured by Medline Industries Inc..
[102732601]
It was reported that toward the end of an unknown procedure a blue string from the x-ray detectable gauze was found in the surgical site. The surgeon was required to remove the blue string from the surgical site via an unknown method. No other information has been provided. Despite multiple good faith efforts to obtain additional information, the initial reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer. The reported sample was discarded and was not available to be returned to the manufacturer for evaluation. Due to the need for additional medical intervention to remove the reported blue string from the surgical site, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[102732602]
It was reported that toward the end of an unknown procedure a blue string from the x-ray detectable gauze was found in the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00010 |
| MDR Report Key | 7343318 |
| Date Received | 2018-03-15 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-02-20 |
| Date Added to Maude | 2018-03-15 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | MINOR PACK |
| Product Code | FDE |
| Date Received | 2018-03-15 |
| Catalog Number | DYNJ0843099D |
| Lot Number | 17JK1966 |
| 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 | 2018-03-15 |