MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-22 for MDT2168054XR manufactured by Medline Industries Inc..
[108934358]
It was reported that operating room (or) towels were linting more than normal and reporting facility "found lint on heart valve. " despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details. 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
[108934359]
It was reported that operating room (or) towels were linting more than normal and reporting facility "found lint on heart valve. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00040 |
| MDR Report Key | 7534521 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-04-27 |
| Date Added to Maude | 2018-05-22 |
| 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 | 3 |
| Generic Name | TOWEL,OR,DSP,ST,WHITE,DLX,XR,4/PK,20PK/C |
| Product Code | FRL |
| Date Received | 2018-05-22 |
| Catalog Number | MDT2168054XR |
| Lot Number | 84317060091 |
| 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 | 2018-05-22 |