MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for SFX SPI PDS+ UNI VIO 12IN 2-0 S/A CT-1 SXPP1B410 manufactured by Ethicon Inc..
[186518504]
(b)(4). A manufacturing record evaluation was performed for the finished device, 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. 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. The patient demographic info: age, gender, weight, bmi at the time of index procedure. Date of the initial procedure? The diagnosis and indication for the index surgical procedure? Was the sxpp1b410, lot pgj792 used for the internal suture? On what tissue was the internal suture used? What was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? What were current symptoms following the index surgical procedure? Onset date? Was there any precipitating stress factor for the suture breakage? Can you describe the appearance of the stratafix suture during second procedure? It was reported that? Internal suture broke and? Failed? As well?. Please clarify what is meant by? Failed as well?? Did the stratafix suture break, if so, where (termination, middle, end)? Other relevant patient history/concomitant medications. 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? Please note: two intra-op suture breakages events occurred during same procedure on (b)(6) 2020 were submitted via medwatches 2210968-2020-02495 and 2210968-2020-02496. And one post-op breakage of 3rd suture used at same procedure on (b)(6) 2020 was submitted via 2210968-2020-02497.
Patient Sequence No: 1, Text Type: N, H10
[186518505]
It was reported that the patient underwent a robotic ventral hernia repair surgery on (b)(6) 2020 and the barbed suture was used to complete the procedure. It was reported that the patient presented five days later, and the procedure had to be repeated. It was discovered that the internal barbed suture had broken and failed as well. It is unknown how the patient is doing. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02497 |
| MDR Report Key | 9907897 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-06-25 |
| Date Added to Maude | 2020-03-31 |
| 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.-SAN LORENZO PR |
| Manufacturer Street | 982 ROAD 183 KM 8.3 |
| Manufacturer City | SAN LORENZO PR |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SFX SPI PDS+ UNI VIO 12IN 2-0 S/A CT-1 |
| Generic Name | SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE |
| Product Code | NEW |
| Date Received | 2020-03-31 |
| Model Number | SXPP1B410 |
| Catalog Number | SXPP1B410 |
| Lot Number | PGJ792 |
| 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 | 2020-03-31 |