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 2020-03-27 for SFX SYM PDS+ UNI VIO 18IN 1 S/A CTXB SXPP1A300 manufactured by Ethicon Inc..
[188247113]
(b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10
[188247114]
It was reported that the patient underwent an unknown chest surgery on (b)(6) 2020 and the barbed suture was used. During a surgery, the barbed suture was detached from the needle when pulling the suture. It was not a control release needle. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02439 |
| MDR Report Key | 9892129 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-02 |
| 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.-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 | SFX SYM PDS+ UNI VIO 18IN 1 S/A CTXB |
| Generic Name | SUTURE, SURGICAL, ABSORBABLE |
| Product Code | NEW |
| Date Received | 2020-03-27 |
| Model Number | SXPP1A300 |
| Catalog Number | SXPP1A300 |
| Lot Number | PH6360 |
| 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 |