MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-12-18 for PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT manufactured by Ethicon Inc..
[188036174]
(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. What was the date of the procedure in 2011? What suture was used during procedure in 2011? What was the date of the second procedure? What suture was used during second procedure? If in your possession, may we have a copy of your operative report (2011, 2nd proc, and aug 2019) for each procedure to review which layer of tissue the suture was used? Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact the surgeon for more clinical information to be used for a product quality complaint investigation? If so, please provide the surgeon? S name, contact information and sign release of medical information form. Patient reported adverse event of hives, reaction possibly treated with steroid in 2011 reported via 2210968-2019-90131. Patient reported adverse event of hives, reaction and angioedema treated with steroid on unknown date reported via 2210968-2019-90134, 2210968-2019-90135 and 2210968-2019-90137. Patient reported adverse event of hives, reaction, angioedema treated with steroid in (b)(6) 2019 and current hives reported via 2210968-2019-90138, 2210968-2019-90140 and 2210968-2019-90141.
Patient Sequence No: 1, Text Type: N, H10
[188036175]
It was reported by the patient that they underwent a left total knee arthroplasty utilizing smith nephew system on (b)(6) 2019 and topical skin adhesive was used. The extensor mechanism was tacked with absorbable suture in figure eight followed by running barbed suture. The subcutaneous closure with absorbable suture in running fashion. The subcuticular closure was performed with absorbable suture. Skin adhesive dressing and mildly compressing wrap were applied. The patient tolerated the procedure well. The patient experienced severe allergic reactions 3 to 4 weeks after surgery, not at the site of surgery but systemically with hives and angioedema. The reaction begins with hives and then proceeds to swelling in the face and lips or on the tongue. The patient reported the angioedema usually responds well but can reappear mildly up to two months, and the hives last longer. The patient was treated with tapering doses of prednisone. Patient reported current hives continue. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-91047 |
| MDR Report Key | 9488233 |
| Report Source | CONSUMER |
| Date Received | 2019-12-18 |
| Date of Report | 2019-12-06 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2019-12-18 |
| 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.SAN LORENZO |
| Manufacturer Street | ROAD 183, KM. 8.3 |
| Manufacturer City | SAN LORENZO 00754 |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT |
| Generic Name | SURGICAL SEALANT |
| Product Code | OMD |
| Date Received | 2019-12-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-12-18 |