MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-31 for SURGICEL SNOW 1INX2IN(2.5CMX5.1CM) 2081 manufactured by Ethicon Inc..
[177143903]
Product complaint # (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? Date and name of index surgical procedure? Lot #? What were current symptoms following the index surgical procedure? Onset date? Has any surgical or medical intervention been performed? What is physician? S opinion as to the etiology of or contributing factors to this event? Was there an alleged deficiency of the surgicel that contributed to the patient? S post-operative allergic reaction? What is the patient? S current status? If applicable, will product be returned, return date, tracking information?
Patient Sequence No: 1, Text Type: N, H10
[177143904]
It was reported that a patient underwent a laparoscopic thyroid lobectomy/para thyroid procedure on (b)(6) 2019 and an absorbable hemostat was used. Post operatively, the patient had an allergic reaction. At the conclusion of the procedure the surgeon applied the absorbable hemostat at. 025% bupivacaine with phrine. With in a few minutes the patient was noted as having erythema all around the incision site approximately ten centimeters in all directions. No erythema was noted prior to applying the absorbable hemostat. The patient was treated with oral and topical steroids, in addition to benadryl. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00849 |
| MDR Report Key | 9650774 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-01-31 |
| 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.SAN LORENZO |
| Manufacturer Street | ROAD 183, KM. 8.3 |
| Manufacturer City | SAN LORENZO 00754 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICEL SNOW 1INX2IN(2.5CMX5.1CM) |
| Generic Name | AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED |
| Product Code | LMG |
| Date Received | 2020-01-31 |
| Model Number | 2081 |
| Catalog Number | 2081 |
| 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 | 2020-01-31 |