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 2018-09-25 for UNK_SUTURE UNKNOWN manufactured by Ethicon Inc..
[121699009]
(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. If further details are received at the later date a supplemental medwatch will be sent. What was the name of the procedure? What was the date of the procedure? What tissue layer was the suture used on? What was the condition of the tissue during initial procedure (diseased, weak, healthy)? How was suture placed (continuous or interrupted)? Can you identify the product code of the unknown suture with lot ma3ac? Is lot ma3ac silk suture? What are the patient age, gender, weight, prior medical history? What post op date did the patient present with symptoms of redness and exudate? What is the surgeon? S opinion as to the contributing factor to the patient event? Was a culture taken of the exudate? What were the results? What is the patient current condition? Is this a usual trend for these kinds of cases for these trauma patients in your hospital? What is the baseline skin infection rate for trauma cases in your hospital?
Patient Sequence No: 1, Text Type: N, H10
[121699010]
It was reported that the patient underwent unknown procedure on unknown date and suture was used. The patient experienced wound incision reddish with small amount of exudate. An additional procedure was performed to remove the suture and necrotic tissue. The patient was treated with regular dressing changes. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[123858961]
Pc-(b)(4). Date sent to the fda: (b)(4) 2018. 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 device history records were reviewed and the manufacturing criteria were met prior to the release of this lot. Additional information was requested and the following was obtained: what was the name of the procedure? Resection of right shoulder lipoma what was the date of the procedure? Unk what tissue layer was the suture used on? Unk what was the condition of the tissue during initial procedure (diseased, weak, healthy)? Unk how was suture placed (continuous or interrupted)? Unk can you identify the product code of the unknown suture with lot ma3ac? Unk is lot ma3ac silk suture? Yes what are the patient age, gender, weight, prior medical history? Female and she was born on (b)(4). What post op date did the patient present with symptoms of redness and exudate? (b)(4) 2018. What is the surgeon? S opinion as to the contributing factor to the patient event? Suture was a culture taken of the exudate? What were the results? Unk what is the patient current condition? Stable is this a usual trend for these kinds of cases for these trauma patients in your hospital? Unk what is the baseline skin infection rate for trauma cases in your hospital? Unk
Patient Sequence No: 1, Text Type: N, H10
[126153466]
Pc-(b)(4). The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2018-76009 |
| MDR Report Key | 7907883 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-25 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-06-23 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2018-01-15 |
| Date Added to Maude | 2018-09-25 |
| 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.-CHINA |
| Manufacturer Street | NO.65 GUIQING ROAD CAO HE JING |
| Manufacturer City | SHANGHAI |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK_SUTURE UNKNOWN |
| Generic Name | SUTURE, NONABSORBABLE |
| Product Code | GAK |
| Date Received | 2018-09-25 |
| Catalog Number | UNK |
| Lot Number | MA3AC |
| 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 | 2018-09-25 |