MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for MDT2168304 manufactured by Medline Industries Inc..
[139078021]
It was reported that there were multiple incidents where blue or towels were noted linting during use. The linting from the blue or towels reportedly reached the surgical site for an unidentified number and type of procedures. Irrigation and changing of gloves was reportedly required after linting was noted. No impact to the patient, the procedure, or the total length of the procedure was reported. Due to the reported incident and required medical intervention, this medwatch is being filed. Samples are 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 reevaluated.
Patient Sequence No: 1, Text Type: N, H10
[139078022]
It was reported that linting from blue or towels reached the surgical site/s.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00032 |
| MDR Report Key | 8404588 |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-02-12 |
| Date Added to Maude | 2019-03-08 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | TOWEL,OR,DSP,ST,BLUE,HEAVY,4/PK,20PK/CS |
| Product Code | FRL |
| Date Received | 2019-03-08 |
| Catalog Number | MDT2168304 |
| Lot Number | 84318070121 |
| 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 | 2019-03-08 |