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 2018-08-01 for UNK_SUTURE UNKNOWN manufactured by Ethicon Inc..
[115763317]
(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. The following information was requested, but unavailable: can you clarify the specific number of patients with? Puffiness? That required suture removal? Can you identify the suture name / product code that was used? What was the name of the procedure? What tissue was the suture used on? How was the suture placed (interrupted or continuous)? What post op date did the patient experience? Puffiness?? What post op date was the suture removed from the patient? What was the indication for suture removal? Can you provide the patient age, gender, weight, prior medical history? Can you describe the appearance of the suture during second procedure? What is the current condition of the patient?
Patient Sequence No: 1, Text Type: N, H10
[115763318]
It was reported by the rep post op after an unknown procedure patients were experiencing "puffyness" around the suture line. When the sutures were removed the condition subsided. There is no additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-74824 |
| MDR Report Key | 7740475 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-01 |
| Date of Report | 2018-07-11 |
| Date Mfgr Received | 2018-07-11 |
| Date Added to Maude | 2018-08-01 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK_SUTURE UNKNOWN |
| Generic Name | SUTURE, ABSORBABLE, SYNTHETIC |
| Product Code | GAK |
| Date Received | 2018-08-01 |
| Catalog Number | UNK |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-01 |