MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2012-09-28 for DEROYAL 89-7387 manufactured by Merit Medical Systems, Inc..
[3012223]
The hospital reported that in preparation for two separate cath lab cases, the staff encountered a problem with the scalpel in pack. One end of the scalpel is coming apart. The tech tried to fix it and was able to use it with no further problem. In the second case, the scalpel fell apart and was unusable.
Patient Sequence No: 1, Text Type: D, B5
[10433705]
Describe event or problem: the hospital reported that in preparation for two separate cath lab cases, the staff encountered a problem with the scalpel i pack. One end of the scalpel is coming apart. The tech tried to fix it and was able to use it with no further problems. In the second case, the scalpel fell apart and was unusable. Deroyal's raw material number for the defective device is (b)(4). Current inventory was reviewed and found acceptable. The returned sample was forwarded on to the mfr for further investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005011024-2012-00005 |
| MDR Report Key | 2794293 |
| Report Source | 00,06 |
| Date Received | 2012-09-28 |
| Date of Report | 2012-09-19 |
| Date of Event | 2012-08-29 |
| Date Facility Aware | 2012-09-19 |
| Report Date | 2012-09-19 |
| Date Reported to FDA | 2012-09-19 |
| Date Reported to Mfgr | 2012-09-19 |
| Date Mfgr Received | 2012-09-19 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2012-10-25 |
| 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 Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 1600 WEST MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | GDX - SCALPEL, ONE-PIECE |
| Product Code | GDX |
| Date Received | 2012-09-28 |
| Returned To Mfg | 2012-09-25 |
| Model Number | 89-7387 |
| Lot Number | 28037155 |
| Device Expiration Date | 2015-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2012-09-28 |