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 2020-03-18 for MERS WHT 18IN 5-0 D/A RV-2 FB1728G manufactured by Ethicon Inc..
[184651529]
(b)(4). Attempts to obtain the following information has been performed and the following was received. If the further details are received at a later date a supplemental medwatch will be sent. Please verify specific quantity of devices which failed in this procedure event date. How was case completed? Any adverse patient consequences and what medical /surgical intervention was provided to mange them? Lot number. Per the customer no further information available 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. 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.
Patient Sequence No: 1, Text Type: N, H10
[184651530]
It was reported a patient underwent an unknown procedure on an unknown date in 2020 and suture was used. The needle pulled off the strand. No patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02208 |
| MDR Report Key | 9849043 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-18 |
| 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 | MERS WHT 18IN 5-0 D/A RV-2 |
| Generic Name | SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE |
| Product Code | GAT |
| Date Received | 2020-03-18 |
| Model Number | FB1728G |
| Catalog Number | FB1728G |
| 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 | 2020-03-18 |