MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-27 for CAP, BOUFFANT, PROSERIES, LT WT, BLUE, 24" * NON28233B manufactured by Medline Industries, Inc.
[21263248]
At end of day, surgeon removed bouffant cap to find dead lizard inside cap. Picture from smartphone is available. ======================manufacturer response for bouffant cap, cap, bouffant, proseries, lt wt, blue, 24" (per site reporter). ======================the box with the remaining caps was returned to the manufacturer by director materials management. Complaint registered with medline customer services representative. I have actual cap with dead lizard for return to manufacturer as well as picture. Awaiting return labels.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2905986 |
| MDR Report Key | 2905986 |
| Date Received | 2012-11-27 |
| Date of Report | 2012-11-21 |
| Date of Event | 2012-11-13 |
| Report Date | 2012-11-21 |
| Date Reported to FDA | 2012-11-27 |
| Date Added to Maude | 2013-01-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAP, BOUFFANT, PROSERIES, LT WT, BLUE, 24" |
| Generic Name | CAP, SURGICAL |
| Product Code | FYF |
| Date Received | 2012-11-27 |
| Model Number | * |
| Catalog Number | NON28233B |
| Lot Number | 904515696 |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-27 |