MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2013-04-26 for FORCEPS 3711040 WEIL BLAKESLEY SZ0 45UP manufactured by Medtronic Xomed, Inc..
[3430617]
It was reported that the forceps broke at the joint after one use. There was no patient impact reported.
Patient Sequence No: 1, Text Type: D, B5
[10719573]
This device is used for therapeutic purposes. (b)(4). The product has not been returned. Method - no testing methods performed.
Patient Sequence No: 1, Text Type: N, H10
[103689648]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000027-2013-00002 |
| MDR Report Key | 3080795 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2013-04-26 |
| Date of Report | 2013-04-04 |
| Date Mfgr Received | 2013-04-04 |
| Date Added to Maude | 2013-07-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCEPS 3711040 WEIL BLAKESLEY SZ0 45UP |
| Generic Name | FORCEPS, ENT |
| Product Code | KAE |
| Date Received | 2013-04-26 |
| Model Number | 3711040 |
| Catalog Number | 3711040 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-26 |