MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-14 for DISPOSABLE OR TOWELS MDT2168304 manufactured by Medline Industries, Inc..
[127124861]
The patient was receiving a hibiclens prep at the neck for a parathyroid case. The neck was scrubbed and then blotted with a pack of disposable blue towels. Upon removing the towels, the surgeon noticed blue flecks of lint from the towels remaining on the skin after the blot. Pictures were taken and the business director was paged. 3 inventory specialists came to the room to retrieve the towel packaging and obtain the pictures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8068582 |
| MDR Report Key | 8068582 |
| Date Received | 2018-11-14 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-10-29 |
| Report Date | 2018-10-29 |
| Date Reported to FDA | 2018-10-29 |
| Date Reported to Mfgr | 2018-11-14 |
| Date Added to Maude | 2018-11-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE OR TOWELS |
| Generic Name | FIBER, MEDICAL, ABSORBENT |
| Product Code | FRL |
| Date Received | 2018-11-14 |
| Model Number | MDT2168304 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-11-14 |