MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-23 for DEROYAL 30-202 manufactured by Deroyal Guatemala.
[3826225]
During cervical spinal procedure, operating room rn opened a rosebud dissector and it had what appeared to be a very small dead brown insect/ spider in the package.
Patient Sequence No: 1, Text Type: D, B5
[10944599]
This was an isolated event in which the insect went undetected during the manufacturing process. The source of the bug was undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2013-00013 |
| MDR Report Key | 3272487 |
| Report Source | 06 |
| Date Received | 2013-07-23 |
| Date of Report | 2013-06-27 |
| Date of Event | 2013-06-10 |
| Date Facility Aware | 2013-06-10 |
| Report Date | 2013-06-27 |
| Date Reported to FDA | 2013-06-12 |
| Date Reported to Mfgr | 2013-06-27 |
| Date Mfgr Received | 2013-06-27 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2013-08-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES |
| Manufacturer City | GUATEMALA |
| Manufacturer Country | GT |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37849 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | DISSECTOR, SURGICAL |
| Product Code | GDI |
| Date Received | 2013-07-23 |
| Returned To Mfg | 2013-07-05 |
| Catalog Number | 30-202 |
| Lot Number | 27991254 |
| Device Expiration Date | 2016-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL GUATEMALA |
| Manufacturer Address | GUATEMALA GT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-23 |