MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-22 for MDT2168204 manufactured by Medline Industries Inc..
[118103158]
It was reported that use of forceps and irrigation was required to successfully retrieve from the surgical sites the blue fibers coming from linting or towels. Per report, the reported incidents happened during an unknown number of multiple various surgical procedures. General anesthesia was used; however, there was no report of any adverse patient consequences and no effect on the patients' stability as a result of the incidents. No impact to the patients, the procedures, or the total length of the procedures was reported. There was no serious injury or follow-up care reported related to this event. Due to the reported medical intervention and in an abundance of caution, this medwatch is being filed. The sample has been discarded and was not available to be returned for evaluation. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, this report will be reopened and re-evaluated.
Patient Sequence No: 1, Text Type: N, H10
[118103159]
It was reported that use of forceps and irrigation was required to successfully retrieve the pieces of blue fibers coming from linting or towels.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00094 |
| MDR Report Key | 7806241 |
| Date Received | 2018-08-22 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-08-01 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-08-22 |
| 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 | TOWEL,OR,DSP,ST,BLUE,DLX,4/PK,20PK/CS |
| Product Code | FRL |
| Date Received | 2018-08-22 |
| Catalog Number | MDT2168204 |
| Lot Number | 6051711002 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-08-22 |