MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-06-09 for SEALING CAP 89.02BL manufactured by Richard Wolf Medical Instruments.
[1536702]
During a laparoscopic exam with cystectomy and lysis of adhesion, a sliver of the sealing cap came off and was retrieved. An incident report was made. There was no patient consequence. Patient was discharged (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5
[8602339]
The device has not been returned as yet for investigation. Upon receipt of the device we will investigate and send a report to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2010-00013 |
| MDR Report Key | 1725474 |
| Report Source | 05,06 |
| Date Received | 2010-06-09 |
| Date of Report | 2010-06-09 |
| Date of Event | 2010-05-19 |
| Date Mfgr Received | 2010-05-21 |
| Date Added to Maude | 2011-03-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELEANOR HALL |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL |
| Manufacturer Country | US |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | DA PRO RUBBER INC. |
| Manufacturer Street | P.O. BOX 470175 |
| Manufacturer City | TULSA OK 74147017 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74147 0175 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEALING CAP |
| Generic Name | SEALING CAP |
| Product Code | EIE |
| Date Received | 2010-06-09 |
| Model Number | 89.02BL |
| Catalog Number | 89.02BL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Address | VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-09 |