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 2020-03-30 for MONOCRYL VIO 27IN USP5-0 C1023 manufactured by Ethicon Inc..
[188521808]
(b)(4). A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified. Summary: five unopened samples of product were received for analysis. During the visual inspection of five samples, no defects were found on the packages. The samples were opened, and the swage and attachment area were noted to be as expected. The sutures were dispensed without problems and examined along of the strands and no defects were observed. A functional test was performed using an instron and the pull force were above the minimum requirements. Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements additional information was requested, and the following was obtained: what is the name of the initial procedure? Unk. Was the surgery completed successfully? Yes. What was used to complete the surgery? A thread of another lot has been used to finish the procedure. Could you please confirm if this issue occurred 4 times in the same procedure? Only one procedure impacted according to the first declaration. Four suture pull offs which occurred during same procedure were submitted via 2210968-2020-02458, 2210968-2020-02459, and 2210968-2020-02462.
Patient Sequence No: 1, Text Type: N, H10
[188521809]
It was reported that the patient underwent an unknown surgery on (b)(6) 2020 and the suture was used. During the procedure, the strand pulled off spontaneously from the first passage of the suture. The procedure was completed successful with another like suture. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02464 |
| MDR Report Key | 9901118 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-08-22 |
| Date Added to Maude | 2020-03-30 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-JUAREZ |
| Manufacturer Street | AVENIDA DE LAS TORRES 7125 COL SALVACAR |
| Manufacturer City | CIUDAD JUAREZ 32604 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOCRYL VIO 27IN USP5-0 |
| Generic Name | SUTURE, ABSORBABLE, SYNTHETIC |
| Product Code | GAN |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-26 |
| Catalog Number | C1023 |
| Lot Number | PJ5677 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |