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 PDSII VIO 27IN 2-0 S/A SH Z317H manufactured by Ethicon Inc..
[186518988]
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. A manufacturing record evaluation was performed for the finished device batch number pgk745, and no non-conformances were identified. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. What was the name of the procedure? The patient demographic info: gender, weight, bmi at the time of index procedure on what tissue was the suture used? What was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? What tissue was the needle wire retained in for extending procedure? Can you clarify was the procedure extended for 1 hour? Can you clarify the specific time of the extended anesthesia time? Was the needle retrieved during the initial procedure after the x-ray? Was an additional surgical procedure performed to remove the needle? Was additional dissection required in other organs or tissues other than the target tissue? Was there any change in the patient? S post-operative care due to the extended anesthesia time? What instruments were used to grasp the needle? Where was the needle grasped during use? If applicable, will product be returned, return date, tracking information? What is physician? S opinion as to the etiology of or contributing factors to this event? What is the patient? S current status?
Patient Sequence No: 1, Text Type: N, H10
[186518989]
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used. During the procedure, the needle detached from the suture. It was necessary to do an x-ray and to extend the anesthesia for 1 hour to detect the needle and to remove it. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02455 |
| MDR Report Key | 9900748 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-06-26 |
| 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 | PDSII VIO 27IN 2-0 S/A SH |
| Generic Name | SUTURE, SURGICAL, ABSORBABLE |
| Product Code | NEW |
| Date Received | 2020-03-30 |
| Model Number | Z317H |
| Catalog Number | Z317H |
| Lot Number | PGK745 |
| 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 | 1. Required No Informationntervention | 2020-03-30 |