MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-15 for LIGACLIP*MCA MED APPLIER MCM20 manufactured by Ethicon Endo-surgery, Llc..
[179507791]
(b)(4). Batch #unk. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Patient Sequence No: 1, Text Type: N, H10
[179507792]
It was reported that during an unknown procedure, before the device was used on the patient, it was noted that the packing was damaged with one hole as the photo shows. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2020-00343 |
| MDR Report Key | 9594133 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2019-12-20 |
| Device Manufacturer Date | 2019-07-11 |
| Date Added to Maude | 2020-01-15 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Postal | 00969 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGACLIP*MCA MED APPLIER |
| Generic Name | CLIP, IMPLANTABLE |
| Product Code | GDO |
| Date Received | 2020-01-15 |
| Returned To Mfg | 2020-01-14 |
| Catalog Number | MCM20 |
| Lot Number | T40M3D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Address | 475 CALLE C GUAYNABO 00969 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |