N
Patient 1
(B)(4). MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
MAUDE MDR 6554280
- MDR report key
- 6554280
- Report number
- 3003639970-2017-00242
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-04-11
- Date received
- 2017-05-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. NICOLE BROYLES
- Address
- 615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
- Phone
- 314-314-3145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MONOMAX VIOLET 0 (3,5) 150CM HR26 (M) | SUTURES | B.BRAUN SURGICAL SA | NWJ | B0041441 | B0041441 | 117081V013 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-09 | 0 | 1. O |
Event Narratives#
D
Patient 1
COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE FIRST PACK WAS SEALED TO THE SECOND PACK.