MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-27 for PROLENE*BLUE3-0 45CM(1)PS-1 PR P8663T manufactured by Ethicon Inc..
[188521293]
(b)(4). A manufacturing record evaluation was performed for the finished device am2751 number, and no non-conformances were identified. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Additional information was requested and the following was obtained: do you confirm that a suture unit frayed and a suture broke during this lipoma resection procedure? Yes affirmative. How many frayed sutures during use in this single procedure? Initially 1. How many sutures were broken in this single procedure? In total there were 10 units how was the case completed? - another lot was used. Device return status - does not apply as the product was discarded. Note: event related to suture fray and suture broke reported via mw 2210968-2020-01492; additional suture breakage events reported via mw 2210968-2020-01491, 2210968-2020-02423, 2210968-2020-02424, 2210968-2020-02426, 2210968-2020-02427, 2210968-2020-02428, 2210968-2020-02429, 2210968-2020-02430.
Patient Sequence No: 1, Text Type: N, H10
[188521294]
It was reported that the patient underwent resection of lipoma procedure on (b)(6) 2020 and suture was used. During the procedure, the suture was breaking at the time of lipoma resection. A device from another lot was used to complete the procedure. There were no adverse patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02425 |
| MDR Report Key | 9889332 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-06-14 |
| Date Added to Maude | 2020-03-27 |
| 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.-BRAZIL |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA KM 154 |
| Manufacturer City | SAO PAOLO 12240 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 12240 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLENE*BLUE3-0 45CM(1)PS-1 PR |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE |
| Product Code | GAW |
| Date Received | 2020-03-27 |
| Catalog Number | P8663T |
| Lot Number | AM2751 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-27 |