MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-03-05 for A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX 101374001 manufactured by Applied Medical Resources.
[182287585]
Ra has just received the incident device and has been assigned to engineering for evaluation. A follow-up report will be sent upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[182287586]
Complaint 1 of 2: (b)(4). Complaint 2 of 2: (b)(4). Procedure performed: cardiac surgery. On (b)(6) 2020: during a preparation for procedure. Occurred during a pre-use inspection. S-clip did not close. Because we used other products the procedure was completed with no problem. The lot returning is unknown. [distributor] provided these 2 possible lots: lot # 1354137 or 1365527. Intervention: used other products to complete procedure. Patient status: na.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00406 |
| MDR Report Key | 9795923 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-05 |
| 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 | 3 |
| Brand Name | A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX |
| Generic Name | CLIP, VASCULAR |
| Product Code | DSS |
| Date Received | 2020-03-05 |
| Returned To Mfg | 2020-02-27 |
| Model Number | A1602 |
| Catalog Number | 101374001 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-05 |