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 2020-03-05 for MERSILK BLACK 6 1.8M NON-NDL W199 manufactured by Ethicon Inc..
[186304451]
(b)(4). A manufacturing record evaluation was performed for the finished device mgk215 batch number, and no non-conformances were identified. Attempts are being made to retrieve the device. 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 single complaint was reported with multiple events. There are no additional details regarding the additional patient events. Additional information was requested and the following was obtained. If further details are received at a later date a supplemental medwatch will be sent. In the clinic suture material had been used by the department of traumatology and orthopedics 2. 5-3 months before the appearance of adverse events in the department on the patients with reconstructions on all sutured layers in the surgical wound. Then the patients had been discharged to home. After 2. 5-3 months they were hospitalized again in the emergency surgical department. All available information from department of traumatology and orthopedics about patient data is below. Patient data of this complaint ((b)(4)): male, (b)(6) years old, weight 38 kg, re-hospitalization for removal of fistulas. Fistulas formed on both feet after myotendoplasty in 3 months. Fistulas were excised, the remains of the threads were removed. The following information was requested but unavailable: date of the initial surgery. The diagnosis and indication for the index surgical procedure? It was reported the? Surgery was on the foot and ligature fistula formed in scar area on left leg?. Please clarify: on what tissue and location was the suture placed? In what tissue/structure was the fistula located? What was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? What were the current symptoms following the initial procedure? What date did the patient present with symptoms? If second operation was performed, what was the appearance of the suture during the reoperation? If applicable, will product be returned, return date, tracking information other relevant patient history/concomitant medications? Did the operating surgeon observe any suture deficiency or anomaly before, during or after suture placement or during any re-operations? Does the surgeon believe there was any suture deficiency that lead to the post-op complications? What is physician? S opinion as to the etiology of or contributing factors to this event patient? S current status? Note: events reported via mw # 2210968-2020-01780.
Patient Sequence No: 1, Text Type: N, H10
[186304452]
It was reported that the patient underwent myotenoplasty on the foot on an unknown date and suture was used. The patient was discharged to home. After the surgery, ligature fistula formed in scar area on the left leg. The patient underwent rehospitalization for removal of the fistula. It was reported fistulas formed on both feet in three months. The fistulas were excised and the remains of the suture were removed. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01779 |
| MDR Report Key | 9795059 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-05 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2018-06-21 |
| Date Added to Maude | 2020-03-05 |
| 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.-JUAREZ |
| Manufacturer Street | AVENIDA DE LAS TORRES 7125 COL SALVACAR |
| Manufacturer City | CIUDAD JUAREZ 32604 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERSILK BLACK 6 1.8M NON-NDL |
| Generic Name | SUTURE, NONABSORBABLE, SILK |
| Product Code | GAP |
| Date Received | 2020-03-05 |
| Catalog Number | W199 |
| Lot Number | MGK215 |
| 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 | 2020-03-05 |