MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-05 for MCRYL UD 18IN 3-0 S/A PS-2 PRM MP Y497G manufactured by Ethicon Inc..
[186743848]
(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. Additional information was requested and the following was obtained: on what tissue was the suture used? Skin&subcutaneous. What was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? Normal. What skin prep was used on the patient? Hibiclens. Were there any changes in skin prep? No change. How was the suture placed (interrupted or continuous)? Both. What was used to close the skin. 3-0 monocryl. Did only one breast experience the reaction/ dehiscence? If so, which side? Right. Can you describe the amount (in cm) of dehiscence/ opening? 5cm. Was any medical intervention performed when patient returned (b)(6) 2019 with symptoms? Yes. Was medical intervention performed? If yes, please describe. Total resection of the area and resutured. Can you describe the appearance of the monocryl suture during the second procedure on (b)(6) 2020? Looked normal. Do you have any photos of the reaction for evaluation? No. Can you describe the appearance of the monocryl suture during procedure on (b)(6) 2020? Absent. Other relevant patient history/concomitant medications. The incision was paper thin after the reaction to sutures. This was two months following breast augmentation. What is the physician? S opinion as to the etiology of or contributing factors to this event? Probably improper sterilization of the product. What is the patient? S current status? Healed. The following information was requested but unavailable: the patient demographic info: weight, bmi at the time of index procedure. Note: event related to (b)(6) 2019 sent via mw 2210968-2020-01723. Event related to (b)(6) 2020 sent via mw 2210968-2020-01770. Event related to (b)(6) 2020 sent via mw.
Patient Sequence No: 1, Text Type: N, H10
[186743849]
It was reported that the patient underwent breast augmentation and crescent nipple lift on (b)(6) 2019 and suture was used to close the incision. It was reported that the suture was used on the skin and subcutaneous tissue and placed interrupted and continuous. The patient returned on (b)(6) 2019 with darkness along the incision line, burning, pain and 5cm wound dehiscence on the right breast. The patient underwent total resection of the area and resuturing. The patient's tissue was reported as paper-thin. On (b)(6) 2020, the patient experienced dehiscence and underwent resuturing with nylon suture. It was reported that the appearance of the suture used on (b)(6) 2019 was normal. On (b)(6) 2020, the patient experienced dehiscence and underwent tissue rearrangement and reclosure. It was reported that the appearance of the suture used on (b)(6) 2019 was absent. It was reported the patient was discharged and will follow-up on next visit. The patient status was reported as healed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01771 |
| MDR Report Key | 9795564 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-05 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-12-29 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2018-09-20 |
| Date Added to Maude | 2020-03-05 |
| 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.-JUAREZ |
| Manufacturer Street | AVENIDA DE LAS TORRES 7125 COL SALVACAR |
| Manufacturer City | CIUDAD JUAREZ 32604 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCRYL UD 18IN 3-0 S/A PS-2 PRM MP |
| Generic Name | SUTURE, ABSORBABLE, SYNTHETIC |
| Product Code | GAN |
| Date Received | 2020-03-05 |
| Model Number | Y497G |
| Catalog Number | Y497G |
| Lot Number | MK6851 |
| 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 | 2020-03-05 |