MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-02-08 for AO QUICK COUPLING 519020ND manufactured by Newdeal.
[20914772]
The reporter stated that panta instrument set was not complete when it was delivered to the customer and used during a surgical procedure. The quick coupling ao was missing from the set. Teflon rings were also missing from the set. The surgical time was prolonged by about fifteen mins. There was no adverse outcome for the pt.
Patient Sequence No: 1, Text Type: D, B5
[21206505]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2011-00005 |
| MDR Report Key | 2019100 |
| Report Source | 01,05 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-02-08 |
| Date of Event | 2011-01-14 |
| Date Mfgr Received | 2011-01-14 |
| Date Added to Maude | 2012-02-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AO QUICK COUPLING |
| Generic Name | NA |
| Product Code | FTY |
| Date Received | 2011-02-08 |
| Catalog Number | 519020ND |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEWDEAL |
| Manufacturer Address | SAINT PRIEST 69800 FR 69800 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-08 |