MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-07-01 for RADIATION SHIELD 304534-6000-585 manufactured by Carl Zeiss Meditec Ag.
[2072614]
A nurse reported that while a surgical procedure (intraoperative radiation therapy following lumpectomy) was in process, she observed that the intrabeam 20x20 cm sterile shield's packaging looked wet inside. She later described it as a "sticky" liquid type of substance inside the sterile packaging. This particular shield was set aside and another one within the same lot was selected, visually inspected and found to be "normal," and was used during surgery. The shields and/or the wound was cleaned with tegaderm and betadine prior to placement. The shields were placed inside the wound against the breast tissue.
Patient Sequence No: 1, Text Type: D, B5
[9279910]
The suspect package was returned from the site to (b)(4) for eval. Results of eval are not available yet.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615030-2011-00003 |
| MDR Report Key | 2155713 |
| Report Source | 05 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-07-01 |
| Date of Event | 2011-06-24 |
| Date Mfgr Received | 2011-06-28 |
| Date Added to Maude | 2011-07-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JUDY BRIMACOMBE |
| Manufacturer Street | 5160, HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 945687562 |
| Manufacturer Country | US |
| Manufacturer Postal | 945687562 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG |
| Manufacturer Street | GOESCHWITZER STRASSE 51-52 |
| Manufacturer City | JENA 07745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07745 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | CIR #8800004447 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIATION SHIELD |
| Generic Name | RADIATION SHIELD |
| Product Code | JAD |
| Date Received | 2011-07-01 |
| Catalog Number | 304534-6000-585 |
| Lot Number | 110851 |
| Device Expiration Date | 2016-02-01 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-01 |