MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-06 for MDT2168204 manufactured by Medline Industries.
[69105793]
During a procedure, lint from a sterile or towel fell into the surgical site. The towel was being used as a drape around the surgical site. The surgeon noticed a piece of lint in the surgical site and removed it using forceps. The procedure continued without further incident. Sample was received but too small for testing. A root cause cannot be determined. Due to the reported incident and in an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[69105794]
It was reported lint from the or towel fell into incision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2017-00011 |
| MDR Report Key | 6379858 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-06 |
| Date of Report | 2017-03-06 |
| Date of Event | 2017-02-13 |
| Date Mfgr Received | 2017-02-15 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2017-03-06 |
| 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 | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8477703962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | OR TOWEL |
| Product Code | FRL |
| Date Received | 2017-03-06 |
| Catalog Number | MDT2168204 |
| Lot Number | 26016070008 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-06 |