MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-01-02 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[185792303]
(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. Additional information: the actual device batch number associated with this event is not known. The possible batch number was reported as follows: batch t6006 - unknown corresponding product code. 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 are the patient age, weight, bmi, past medical and surgical history? What tissue layer was the unknown suture used on during initial procedure? What was the date of the initial c-section procedure? Please explain? Healing is not ideal?? What was the date of the patient treatment? What is the surgeon opinion as to contributing factors to the symptoms? Can you identify the name/ product code for the lot number t6006 of suture used? Do you have any samples for evaluation? What is the current condition of the patient?
Patient Sequence No: 1, Text Type: N, H10
[185792304]
It was reported that the patient underwent a cesarean section procedure on an unknown date and suture was used. Approximately three days after the procedure, the patient experienced swelling and inflammation at the incision site. The healing is not ideal. After diagnosis, the patient was given anti-allergic and anti-infective therapy immediately. No additional information was provided. The current status of the patient is unknown. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00018 |
| MDR Report Key | 9540980 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-10 |
| Date of Event | 2019-09-01 |
| Date Mfgr Received | 2019-12-10 |
| Date Added to Maude | 2020-01-02 |
| 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.- AURANGABAD |
| Manufacturer Street | 312379@B-15/1 M.I.D.C., 1 WALU |
| Manufacturer City | AURANGABAD |
| Manufacturer Country | IN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, ABSORBABLE |
| Product Code | GAK |
| Date Received | 2020-01-02 |
| 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 | 2020-01-02 |