MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-21 for DYNJ CUSTOM PACK - SEPT-RHINOPLASTY-TROY PK-LF DYNJ0396069F manufactured by Medline Industries, Inc.
[100643207]
Patient Sequence No: 1, Text Type: N, H10
[100643208]
During case set up, black particles were found on the underside of the basin wrap and on the drapes in the septo-rhinoplasty troy pack from medline. Materials were removed from the field and a new set up was obtained. No harm came to the patient and the procedure was completed as planned with the new set up. Manufacturer response for surgical pack, dynj pack - sept-rhinoplasty-troy pk-lf (per site reporter). Medline is investigating pack contamination currently. We will update medsun with information as it becomes available to us.
Patient Sequence No: 1, Text Type: D, B5
[103560871]
Patient Sequence No: 1, Text Type: N, H10
[103560872]
During case set up, black particles were found on the underside of the basin wrap and on the drapes in the septo-rhinoplasty troy pack from medline. Materials were removed from the field and a new set up was obtained. No harm came to the patient and the procedure was completed as planned with the new set up. Manufacturer response for surgical pack, dynj pack - sept-rhinoplasty-troy pk-lf (per site reporter). Medline is investigating pack contamination currently. We will update medsun with information as it becomes available to u. S.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7285376 |
| MDR Report Key | 7285376 |
| Date Received | 2018-02-21 |
| Date of Report | 2018-02-12 |
| Date of Event | 2018-02-01 |
| Report Date | 2018-02-12 |
| Date Reported to FDA | 2018-02-12 |
| Date Reported to Mfgr | 2018-02-12 |
| Date Added to Maude | 2018-02-21 |
| 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 | DYNJ CUSTOM PACK - SEPT-RHINOPLASTY-TROY PK-LF |
| Generic Name | CUSTOM SURGICAL PACK |
| Product Code | MMO |
| Date Received | 2018-02-21 |
| Returned To Mfg | 2018-02-02 |
| Model Number | TROY PK-LF |
| Catalog Number | DYNJ0396069F |
| Lot Number | 16KD0473 |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC |
| Manufacturer Address | 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-21 |