MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-16 for AVID CUSTOM PROCEDURE TRAYS N021 manufactured by Owens & Minor, Tec..
[75751810]
Operating room staff reported finding hair located within the plastic bag of the custom pack. Pack could not be used. Manufacture date: 12/29/2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069879 |
| MDR Report Key | 6578035 |
| Date Received | 2017-05-16 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-03-31 |
| Date Added to Maude | 2017-05-19 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | AVID CUSTOM PROCEDURE TRAYS |
| Generic Name | CYSTO PACK / TRAY, SURGICAL |
| Product Code | LRP |
| Date Received | 2017-05-16 |
| Catalog Number | N021 |
| Lot Number | 1203396 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR, TEC. |
| Manufacturer Address | 9120 LOCKWOOD BLVD. MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-16 |