MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-04 for MCRYL UD 18IN 3-0 S/A PS-2 PRM MP Y497G manufactured by Ethicon Inc..
[186285316]
(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. The diagnosis and indication for the index surgical procedure? What tissue type and location of the suture placement? What tissue dehisced? What was the tissue condition, i. E. , normal or thin, calcified, fragile, diseased? 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? Did all the reported issues occur in the left breast? If not, please indicate which breast experienced the reported issues on (b)(6) 2019, (b)(6) 2019, (b)(6) 2019 and (b)(6) 2019? It was reported that cultures were performed on (b)(6) 2019. Were cultures performed on (b)(6) 2019, (b)(6) 2019 and (b)(6) 2019? If yes, results? On (b)(6) 2019, what tissue was resutured with 4-0 pds? Product code and lot # for 4-0 pds? Were all sutures (y497g, 4-0 pds) removed on (b)(6) 2019? Was only 4-0 nylon removed on (b)(6) 2019? Other relevant patient history/concomitant medications if applicable, will product be returned, return date, tracking information what is physician? S opinion as to the etiology of or contributing factors to this event? Events captured in mw 2210968-2020-01735, 2210968-2020-01738.
Patient Sequence No: 1, Text Type: N, H10
[186285317]
It was reported that the patient underwent incision and drainage procedure of left breast in (b)(6) 2019 and suture was used. The patient returned on (b)(6) 2019, incision dehisced and was oozing serum from left breast incision. Incision was cleaned, covered and the patient was prescribed another prescription of levaquin, 500 mg for seven days. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01736 |
| MDR Report Key | 9788448 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-09-12 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2018-09-20 |
| Date Added to Maude | 2020-03-04 |
| 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.-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 | 2020-03-04 |
| 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 | 2020-03-04 |