MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-20 for COTTON-LORENZ LARYNGEAL PROSTHESIS 7.5MM N/A 06-1075 manufactured by Biomet Microfixation.
[106137762]
Zimmer biomet complaint (b)(4). (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[106137763]
It was reported since the procedure reported in 0001032347-2018-00031 "the child has been brought back to the operating room numerous times for dilation of airway. We are going to bring him back soon to have another reconstructive surgery. " attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00211 |
| MDR Report Key | 7448185 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-20 |
| Date of Report | 2018-09-26 |
| Date Mfgr Received | 2018-09-20 |
| Date Added to Maude | 2018-04-20 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COTTON-LORENZ LARYNGEAL PROSTHESIS 7.5MM |
| Generic Name | STENT |
| Product Code | FWN |
| Date Received | 2018-04-20 |
| Model Number | N/A |
| Catalog Number | 06-1075 |
| Lot Number | UNKNOWN |
| ID Number | (01)00841036025953 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-04-20 |