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 2020-02-18 for MCRYL UD 27IN 3-0 S/A PS-2 PRM MP Y427H manufactured by Ethicon Inc..
[185928491]
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 on what tissue was the suture used? What was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? What were current symptoms following the index surgical procedure? Onset date? Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? Did the patient receive any prophylactic antibiotics pre-, intra-op? Were cultures performed? Results? One patient instance ((b)(4)) reported ethilon product code 1669h and monocryl suture product code y427h. Were both sutures involved in this patient event? If yes, in what tissue was the ethilon suture and the monocryl suture used? Please provide lot number for the monocryl suture. Other relevant patient history/concomitant medications. Lot # for the ethilon suture. Will product for the same product code/lot number be returned for evaluation? Return date, tracking information? What is physician? S opinion as to the etiology of or contributing factors to this event? What is the patient? S current status? Ethicon device captured in mw 2210968-2020-01255.
Patient Sequence No: 1, Text Type: N, H10
[185928492]
It was reported that the patient underwent a carpal tunnel procedure on an unknown date and suture was used. The area around the incision was infected and the skin around the incision was red. The patient was treated with antibiotics. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01253 |
| MDR Report Key | 9723103 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCRYL UD 27IN 3-0 S/A PS-2 PRM MP |
| Generic Name | SUTURE, ABSORBABLE, SYNTHETIC |
| Product Code | GAN |
| Date Received | 2020-02-18 |
| Model Number | Y427H |
| Catalog Number | Y427H |
| 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 | 2020-02-18 |