MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-10-05 for FUTURA SAFETY SCALPEL SMS210/C manufactured by Merit Medical Systems, Inc..
[1178508]
Reason for product recall: merit medical systems, inc. Is recalling a specific shipment of products due to potential sterility breach which may have been caused by excessive shipment damage. Please note there have been no adverse events reported that are associated with this recall.
Patient Sequence No: 1, Text Type: D, B5
[8423293]
Merit is recalling products of a specific shipment due to a potential sterility breach which may have been caused by excessive shipment damage. A delivery truck transporting the products was involved in a roll-over accident; nevertheless, the deliveries were made without merit's consent. Device evaluation: the device packaging will be inspected if returned. If the product was used and returned, it will be evaluated. Evaluation codes: conclusions - if additional information becomes available, it will be submitted to fda in accordance with statutory product retrieval reporting requirements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721504-2009-00127 |
| MDR Report Key | 1493632 |
| Report Source | 00 |
| Date Received | 2009-10-05 |
| Date of Report | 2009-09-28 |
| Date of Event | 2009-09-25 |
| Date Mfgr Received | 2009-09-28 |
| Device Manufacturer Date | 2009-09-08 |
| Date Added to Maude | 2009-10-08 |
| 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 | STEPHANIE ERSKINE |
| Manufacturer Street | 1600 MERIT PKWY. |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084349 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1721504-10/13/09-003-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUTURA SAFETY SCALPEL |
| Generic Name | SCALPEL, ONE-PIECE |
| Product Code | GDX |
| Date Received | 2009-10-05 |
| Model Number | NA |
| Catalog Number | SMS210/C |
| Lot Number | D914622 |
| ID Number | NA |
| Device Expiration Date | 2012-05-31 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | SOUTH JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-05 |