MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-10 for UNK manufactured by Applied Medical Resources.
[134413861]
No product is being returned for evaluation and no lot # has been provided to manufacturer. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[134413862]
Procedure performed: unk. Limited information available at this time. Rep heard this information from a surgeon who had heard it from a tech that was in a case with another surgeon. Rep is trying to obtain more information. Ripped green coating off scissors to get it to fit into the 5mm trocar. Additional information received via email on 11dec2018 from applied medical account manager: i have been able to get the surgeons name but no other information yet. The or manager is planning to speak to the surgeon tmrw. Additional information was received via telephone on 26dec2018 11:01am from applied medical account manager: the model of the device would be either the cb030 or cb040. The rep has made multiple attempts via email and in person and no further information is available. The surgeon had trouble getting the scissors into the trocar. The surgeon that originally spoke with the account manager did not know the name of the tech nor the name of the surgeon involved in the case. Patient status: no patient injury reported. Type of intervention: unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00315 |
| MDR Report Key | 8234059 |
| Date Received | 2019-01-10 |
| Date of Report | 2019-03-20 |
| Date Mfgr Received | 2018-11-28 |
| Date Added to Maude | 2019-01-10 |
| 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 | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNK |
| Generic Name | UNK |
| Product Code | HET |
| Date Received | 2019-01-10 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-10 |