MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-25 for MCRYL UD 18IN 3-0 S/A PS-2 PRM MP Y497G manufactured by Ethicon Inc..
[186300824]
(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 the index surgical procedure. Can you clarify the lot number used? The diagnosis and indication for the initial surgical procedure? On what tissue was the suture used? What was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? What was the onset date of symptoms from the initial surgical procedure? Can you explain what is meant by? Tissue being eaten away?? Do you have any photos for review? Was medical intervention performed? If yes, please describe. What was the date of the second procedure? Can you describe the appearance of the suture during the second procedure? Were pre, peri or post- operative antibiotics prescribed? What was the indication for prescribing antibiotics? Were cultures performed? If so, what are the results? Other relevant patient history/concomitant medications what is the physician? S opinion as to the etiology of or contributing factors to this event? What is the patient? S current status? The lot number of mk5861 is invalid. Can you please provide the correct lot number?
Patient Sequence No: 1, Text Type: N, H10
[186300825]
It was reported that a patient underwent a plastic surgery procedure on an unknown date and suture was used. Post operative, the patient presented with symptoms of the tissue being eaten away at the incision site due to a reaction. The patient was treated with oral and topical antibiotics. It was reported that it was possible the patient's incision had to be completely redone. The implant had to be removed. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01471 |
| MDR Report Key | 9752246 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-25 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-25 |
| 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. |
| 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 | 2020-02-25 |
| Model Number | Y497G |
| Catalog Number | Y497G |
| 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 | 2020-02-25 |