MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-01 for MEDLINE INDUSTRIES, INC. PHS397101008 manufactured by Medline Industries, Inc..
[90753511]
Patient Sequence No: 1, Text Type: N, H10
[90753512]
Operating room (or) opened for laparoscopic preperitoneal bilateral inguinal hernia repairs with a minor abdominal pack. The surgical team opened for the procedure, when the sa noted a long, black hair within the laparotomy sponge. A picture was taken, the room was torn down, and the pack was given to the charge lead nurse. Quality and safety, as well as the manufacturer representative, were made aware. A new pack was set up and the procedure was completed as planned with no harm to the patient. Per site reporter: the manufacturer representative was notified and picked up the contaminated pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6992771 |
| MDR Report Key | 6992771 |
| Date Received | 2017-11-01 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-10-19 |
| Report Date | 2017-10-31 |
| Date Reported to FDA | 2017-10-31 |
| Date Reported to Mfgr | 2017-10-31 |
| Date Added to Maude | 2017-11-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | MEDLINE INDUSTRIES, INC. |
| Generic Name | GENERAL SURGERY TRAY |
| Product Code | LRP |
| Date Received | 2017-11-01 |
| Returned To Mfg | 2017-10-20 |
| Model Number | PHS397101008 |
| Catalog Number | PHS397101008 |
| Lot Number | 17HD2883 |
| Device Availability | R |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1160 S. NORTHPOINT BLVD. WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-01 |