MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-21 for OBTURATOR,INTEL 4MM A'SP FOR 4356 manufactured by Smith & Nephew, Inc..
[112227780]
Patient Sequence No: 1, Text Type: N, H10
[112227781]
It was reported black debris in the joint. There was a backup device available and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[114078157]
One 4mm obturators were returned for evaluation. Visual assessment of the device showed no defects that would contribute to the reported complaint. The device was tested with a 6mm high flow double valve cannula and was found to function as intended. This investigation could not identify any evidence of product contribution to the reported complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2018-00779 |
| MDR Report Key | 7627798 |
| Date Received | 2018-06-21 |
| Date of Report | 2018-07-16 |
| Date of Event | 2018-05-19 |
| Date Mfgr Received | 2018-07-13 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-06-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OBTURATOR,INTEL 4MM A'SP FOR |
| Generic Name | POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE |
| Product Code | NHB |
| Date Received | 2018-06-21 |
| Returned To Mfg | 2018-07-06 |
| Model Number | 4356 |
| Catalog Number | 4356 |
| Lot Number | 50690404 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-21 |