MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-12-17 for PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT manufactured by Ethicon Inc..
[188032342]
Product complaint # (b)(4). Sent to the fda. (b)(4). Attempts to obtain the following information have been made, no response has been received to date. 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. Does the surgeon believe that ethicon products (prineo, stratafix suture and monocryl suture) involved caused and/or contributed to the post-operative complications described in the article? What was the indication of dog-ear corrections? Were these related to the sutures used in wound closure such as monocryl sutures and stratafix sutures? Which group did the minor granuloma occur? Does the surgeon believe there was any deficiency with the ethicon products (prineo, stratafix suture and monocryl suture) used in this procedure? (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188032343]
Title : a comparative trial of incisional negative-pressure wound therapy in abdominoplasty. Author : gerald m. Abesamis, md, shiv chopra, mbbs, bsc, mrcs, karen vickery, bvsc, phd, anand k. Deva, bsc , mbbs, ms, fracs. Citation: plast reconstr surg glob open 2019;7:e2141; doi: 10. 1097/gox. 0000000000002141. This prospective consecutive cohort study aimed to determine whether the use of incisional negative-pressure wound therapy (inpwt) dressing in patients undergoing an abdominoplasty can reduce postoperative drainage output and adverse events compared to standard postoperative dressings. A total of 16 female patients who underwent abdominoplasty were divided into two groups based on the dressing technique: control group which utilized standard dressings (n=7; mean age of 49 years [ranged 33-61 years]; mean average body mass index of 35. 36kg/m^2 [ranged 23. 7-57. 9 kg/m^2]) and treatment group which utilized inpwt (n=9; mean age of 41 years; average bmi of 29. 94 kg/m^2 [ranged 25. 4-37. 1 kg/m^2]). In the procedure, standard layered closure of the scarpa? S and skin layers was done using 3-0 and 4-0 resorbable monofilament sutures (monocryl and stratafix, ethicon) on both groups. In the control group, skin was dressed with adhesive and tapes (prineo); while inpwt prevena system was utilized in the treatment group. Complications included hypertrophic scars (n=1) which underwent subsequent steroid/laser therapy; 3 patients requiring dog-ear corrections at the 6-month mark; and a minor granuloma and delayed wound healing of umbilicus (n=1) which resolved with topical silver treatment within 2 weeks. Surgical strategies that reduce drainage in abdominoplasty also include using progressive tension sutures and tissue adhesives. The findings showed that inpwt for a closed abdominoplasty incision decreases the rate of postoperative fluid accumulation and results in earlier drain removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-91017 |
| MDR Report Key | 9484692 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-12-17 |
| Date of Report | 2019-12-05 |
| Date Mfgr Received | 2019-12-05 |
| Date Added to Maude | 2019-12-17 |
| 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 | 2019-12-17 |
| 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 | 2019-12-17 |