MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study report with the FDA on 2020-01-10 for GUT CHROMIC SUTURE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[185897755]
(b)(4). This report is related to data research, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events. If further details are received at a later date a supplemental medwatch will be sent. Additional device captured in mw 2210968-2020-00252.
Patient Sequence No: 1, Text Type: N, H10
[185897756]
It was reported via clinical evaluation report from a related research activity database (drra) that patients underwent an unknown procedure on unknown date and suture was used. The reported complication experienced by the following with corresponding intervention: 6 patients had bleeding peri-operative complication after the procedure. 1 patient had sepsis peri-operative complication after the procedure. 2 patients had surgical site infection peri-operative complication after the procedure. 3 patients had wound disruption peri-operative complication after the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00257 |
| MDR Report Key | 9575313 |
| Report Source | COMPANY REPRESENTATIVE,STUDY |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-14 |
| Date Mfgr Received | 2019-12-14 |
| Date Added to Maude | 2020-01-10 |
| 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. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUT CHROMIC SUTURE UNKNOWN PRODUCT |
| Generic Name | SUTURE, ABSORBABLE, NATURAL |
| Product Code | GAL |
| Date Received | 2020-01-10 |
| 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 | 2020-01-10 |