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 VICRYL ABS SUR SUT USP SYN NW2317 manufactured by Ethicon Inc..
[185215676]
(b)(4). A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified. Attempts were made to obtain the device return for evaluation. 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: could you please confirm what was the initial procedure? Patient procedure was open myomectomy. What is the condition of the patient? Patient has no co morbidities, fit and well. Were x-rays taken to locate the needle piece(s)? Yes. Was the needle piece(s) retrieved during the same procedure? Yes. Does a piece of the needle remain in the patient? S tissue? No, was retrieved under the x-ray. What tissue structure is it located? Size of the needle piece retained? First layer of the uterus, needle was split into two. Are any plans in place to remove the needle piece in future? Has been removed. If retained, what is the surgeon's opinion of consequences to the patient? Not retained. Was there any additional tissue damage as a result of searching for the needle piece? A bit of dissection done on the second layer of the uterus. Device return - staff unfortunately thrown in the sharps bin but too late to pick up to send to company for analysis.?
Patient Sequence No: 1, Text Type: N, H10
[185215677]
It was reported that the patient underwent a myomectomy on unknown date and the suture was used. It was reported that on first layer of the uterus, the needle broke, split into two. The needle was retrieved from the patient under x-ray. A bit of dissection was done on the second layer of the uterus. The patient has no comorbidities, fit and well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02411 |
| MDR Report Key | 9887258 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-10-01 |
| 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.-GMBH |
| Manufacturer Street | ROBERT-KOCH STRASSE 1 |
| Manufacturer City | NORDERSTEDT D22851 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D22851 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VICRYL ABS SUR SUT USP SYN |
| Generic Name | SUTURE, ABSORBABLE, SYNTHETIC |
| Product Code | GAM |
| Date Received | 2020-03-27 |
| Catalog Number | NW2317 |
| Lot Number | MLBDZPQ0 |
| 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 |