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 SILK SUTURE UNKNOWN PRODUCT manufactured by Ethicon Inc..
[186809624]
(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. 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. The diagnosis and indication for the index surgical procedure? On what tissue was the suture used? What was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? Were cultures performed? If yes, results? Other relevant patient history/concomitant medications. Product code and lot number. If applicable, will product be returned, return date, tracking information. What is the physician? S opinion as to the etiology of or contributing factors to this event? What is the patient? S current status?
Patient Sequence No: 1, Text Type: N, H10
[186809625]
It was reported that the patient underwent sewing in skin laceration of right hand on (b)(6) 2019 and suture was used. Doctors used silk suture to sew patient wounds as per normal procedure. On (b)(6) 2019, the patient suffered from erythema inflammation, and pain around the wound. The patient was treated with stitches removed and re-sutured, and cefalexin capsules 0. 25 g, 12 capsules, 2 capsules/time, 3 times a day. For two days later, the symptoms of erythema, inflammation and pain were improved. Then the patient's condition changed to better. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02431 |
| MDR Report Key | 9889422 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-08-15 |
| Date Mfgr Received | 2020-02-28 |
| 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. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILK SUTURE UNKNOWN PRODUCT |
| Generic Name | SUTURE, NONABSORBABLE, SILK |
| Product Code | GAP |
| Date Received | 2020-03-27 |
| 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 | 2020-03-27 |